issue-1996-05-01•Federal Register proposed rules — 1996-05-01
Federal Register proposed rules — 1996-05-01
issue-1996-05-01Federal Register proposed rules — 1996-05-01Proposed Regulation
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FR Doc. 96-9988 Magnuson Act Provisions; Consolidation and Update of Regulations
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19390-19429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9988]
[[Page 19389]]
_______________________________________________________________________
Part IV
Department of Commerce
_______________________________________________________________________
National Oceanic and Atmospheric Administration
_______________________________________________________________________
50 CFR Parts 600, 601, 602, et al.
Magnuson Act Provisions; Consolidation and Update of Regulations;
Proposed Rule
Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 /
Proposed Rules
[[Page 19390]]
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Parts 600, 601, 602, 603, 605, 611, 619, 620, and 621
[Docket No. 960315081-6081-01; I.D. 030596B]
RIN 0648-AI17
Magnuson Act Provisions; Consolidation and Update of Regulations
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Proposed rule; request for comments.
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SUMMARY: NMFS proposes to consolidate nine CFR parts into one part that
would contain general provisions under the Magnuson Fishery
Conservation and Management Act (Magnuson Act) as they apply to the
operation of Regional Fishery Management Councils (Councils) and the
management of foreign and domestic fishing in the U.S. Exclusive
Economic Zone (EEZ). The consolidated text would be reorganized into a
more logical and cohesive order, duplicative and outdated provisions
would be eliminated, and editorial changes would be made for
readability, clarity, and uniformity. In addition, the proposed rule
would make several revisions to the regulations applying to the
operation of the Councils, to codify recent administrative and policy
changes. The purpose of this proposed rule is to make the regulations
more concise, better organized and, therefore, easier for the public to
use, and to update the regulations to reflect current policies and
procedures. This proposed action is part of the President's Regulatory
Reinvention Initiative.
DATES: Comments must be received on or before May 31, 1996.
ADDRESSES: Comments should be sent to Tom Meyer, Office of Fisheries
Conservation and Management, NMFS, 1315 East-West Highway, Silver
Spring, MD 02910. Comments regarding burden-hour estimates or other
aspects of the collection-of-information requirements contained in this
rule should be sent to Tom Meyer at the above address and to the Office
of Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20503 (Attention: NOAA Desk Officer).
FOR FURTHER INFORMATION CONTACT: Tom Meyer, 301-713-2337.
SUPPLEMENTARY INFORMATION:
Background
In March 1995, President Clinton issued a directive to Federal
agencies regarding their responsibilities under his Regulatory
Reinvention Initiative. This initiative is part of the National
Performance Review and calls for comprehensive regulatory reform. The
President directed all agencies to undertake a review of all their
regulations, with an emphasis on eliminating or modifying those that
are obsolete, duplicative, or otherwise in need of reform. This
proposed rule is intended to carry out the President's directive with
respect to those regulations implementing general provisions of the
Magnuson Act.
Consolidation of regulations into one CFR part (50 CFR part 600).
Currently, regulations pertaining to general provisions of the Magnuson
Act are contained in nine separate parts of title 50 of the CFR. NMFS
is proposing to remove eight of the parts (parts 601 (Regional Fishery
Management Councils), 602 (Guidelines for Fishery Management Plans),
603 (Confidentiality of Statistics), 605 (Guidelines for Council
Operations/Administration), 611 (Foreign Fishing), 619 (Preemption of
State Authority under Section 306(b)), 620 (General Provisions for
Domestic Fisheries), and 621 (Civil Procedures)), and to consolidate
the regulations contained therein, except for part 605, with the
existing regulations in part 600. The proposed rule would remove part
605 (Guidelines for Council Operations/Administration), and the
material contained in that part would be placed into a Council
Operations and Administration Handbook. These consolidated regulations
would provide the public with a single reference source for the general
regulations under the Magnuson Act as they apply to the operation of
Councils and the management of foreign and domestic fishing in the EEZ;
consolidation would result in one set of regulations that is more
concise, clearer, and easier to use than the existing regulations.
Reorganization of measures within the consolidated regulations and
elimination of obsolete or duplicative provisions. NMFS proposes to
simplify and shorten the codified general Magnuson Act regulations.
Because portions of the existing regulations contain identical or
nearly identical provisions, this rule would combine and restructure
text. Regulatory language would be revised to improve clarity and
consistency.
As a result of the consolidation effort, NMFS identified
duplicative and obsolete provisions; this rule also proposes to remove
those measures from the regulations. This occurs in two areas: (1)
Foreign fishing (subpart F)--proposed revisions to the foreign fishing
regulations would eliminate appendices and sections dealing with
geographical areas where foreign fishing no longer occurs (all but the
Northwest Atlantic fisheries), and update the remaining text to reflect
that only foreign joint venture fishing is currently authorized, and
the need for gear restrictions, closed areas, and gear conflict
regulations are reduced; and (2) the national standards (subpart D)--
the proposed revision would eliminate appendix A, since this
explanatory material and supplementary policy rationale were previously
published in the Federal Register (54 FR 30833, July 24, 1989). No
substantive changes, except for those specifically identified, are
intended to be made to the regulations by this proposed reorganization,
or by the removal of duplicative and obsolete provisions.
The following proposed revisions are substantive changes:
(1) Definitions for the terms ``harass'' and ``sexually harass''
would be added to Sec. 600.10. Prohibitions are proposed to make
unlawful harassment or sexual harassment of an authorized officer or an
observer (Sec. 600.725(o)). In addition, the word ``forcibly'' would be
removed from the prohibitions at Secs. 600.505(a)(3) and (a)(14) and at
600.725(f). Authorized officers and observers should not be subjected
to resistance, intimidation, or interference, whether or not force is
involved.
(2) The constituent states of the Councils are represented by
``principal state officials'' designated by their governors. Each
principal state official under section 302(b) of the Magnuson Act would
be required to be employed, on a full-time basis, in a position related
to the development of fisheries management policies for that state.
Each Governor, when making new or revised designations to a Council of
a principal state official and their designee(s), would submit to the
NMFS Regional Director in writing, within a specified timeframe,
documentation that clearly demonstrates how such individuals meet the
new criteria for designation. When a principal state official names a
designee, that official would also have to ensure that the required
documentation is provided in advance, in a timely manner, to the NMFS
Regional Director. Additionally, this section would specify that
principal state officials who do not meet the new criteria or do not
submit the required
[[Page 19391]]
documentation would not be able to vote (Sec. 600.205).
(3) Additional policies regarding term limits for Secretarial
appointees would be established: one day or more of a voting member's
Council service would be counted as service for the entire 3-year term
of office; voting members, appointed to complete expiring terms, would
be considered to have served the entire term when the remainder of that
expiring term is completed; and voting members who have completed three
consecutive terms would not be considered for appointment to another
Council until one year has elapsed since they last served
(Sec. 600.210).
(4) Governors would be able to nominate residents of another
constituent state of a Council for appointment to an at-large seat on
that Council. Instructions pertaining to the nomination of at-large
nominees would be revised such that, if a Governor chooses to submit
nominations for one or more vacant at-large seats on a Council, he/she
must submit lists of at least three different nominees for each vacant
seat (Sec. 600.215).
(5) Policies in accordance with section 302(b)(5)of the Magnuson
Act regarding removal of Secretarial appointees for cause would be
added. A recommendation of a Council to remove a member would have to
be made to the Secretary in writing accompanied by a statement of the
basis for such recommendation (Sec. 600.230).
(6) Additional timeframes have been specified for when each Council
nominee, voting member appointed to the Council by the Secretary, and
Executive Director is required to complete and submit the NOAA Form 88-
195 (``Statement of Financial Interests for Use by Voting Members,
Nominees, and Executive Directors of the Regional Fishery Management
Councils''). In addition, the NOAA Form 88-195 must be made available
for inspection at each public Council meeting or hearing
(Sec. 600.235).
(7) Issuance of security assurances to Council nominees and members
would be substituted for security clearances, which would only be
considered for issuance on a case-by-case basis by the Department of
Commerce Office of Security. Each Council nominee would have to
complete a ``Certification of Status'' form, certifying whether he/she
serves as an agent of a foreign principal (Sec. 600.240).
(8) Section 302(d) of the Magnuson Act establishes GS-16 of the
General Schedule as Council member's daily pay rate. The GS-16 pay rate
has been abolished. The proposed rule would establish a Council
member's pay rate at 1.2 times the daily rate for GS-15 (step 1) of the
General Schedule (without locality pay), which is equivalent to the
previous GS-16 pay rate (Sec. 600.245).
(9) Contractors of a Council would be given access to confidential
data (Sec. 600.415(d)(3)).
Proposed rule on scientific research activity and exempted fishing.
A proposed rule on ``Foreign and Domestic Fishing; Scientific Research
Activities and Exempted Fishing'' was published by NMFS on March 14,
1996 in the Federal Register at 61 FR 10712. The regulatory text of the
scientific research activity proposed rule has been included in this
proposed rule for the convenience of the public, in the following
locations: (1) Sec. 600.10--definitions for: Director, exempted
educational activity, exempted or experimental fishing, scientific
cruise, scientific research activity, scientific research plan, and
scientific research vessel; (2) Sec. 600.505(a)(27)--prohibition; (3)
Sec. 600.512--scientific research; (4) Sec. 600.725(k) through (n); and
(5) Sec. 600.745--scientific research activity, exempted fishing, and
exempted educational activity. NMFS has requested comments on the
scientific research activity proposed rule during the comment period
for that rule, and is not requesting comments on that proposed text
here. Any changes to the scientific research activity proposed rule
made at the final rule stage will be reflected in the final rule for
the consolidation of part 600.
Request for comments. NMFS specifically requests comments or
suggestions for further consolidation or elimination of obsolete or
duplicative provisions contained in the proposed revision to part 600.
Classification
This action has been determined to be not significant for purposes
of E.O. 12866.
The Assistant General Counsel for Legislation and Regulation of the
Department of Commerce certified to the Chief Counsel for Advocacy of
the Small Business Administration that this proposed rule, if adopted,
would not have a significant economic impact on a substantial number of
small entities. The proposed consolidations and revisions to the
existing regulatory text would have little or no impact on any small
entities. Proposed revisions to Council membership procedures would
have little impact on Council operations, because the rule is merely
codifying changes that, for the most part, are already known to the
Councils and are already in practice.
This rule contains collection-of-information requirements subject
to the Paperwork Reduction Act (PRA). Approved Collection-of-
Information Requirements The following collection-of-information
requirements have already been approved by OMB for foreign fishing
activities:
(a) Approved under 0648-0089--Foreign fishing permits, estimated at
2 hours per response.
(b) Approved under 0648-0075--Vessel reports (1) activity reports
estimated at 0.1 hours per response, (2) weekly reports estimated at
0.5 hours per response, and (3) marine mammal report estimated at 0.2
hours per response; Observers (1) effort plan estimated at 0.5 hours
per response, and (2) notification requirement to observers estimated
at 0.2 hours per response; Recordkeeping (1) communications logs
estimated at 0.1 hours per response, (2) transfer logs estimated at 0.2
hours per response, (3) daily fishing logs estimated at 0.4 hours per
response, (4) daily consolidated fishing log estimated at 0.5 hours per
response, and (5) joint venture logs estimated at 0.5 hours per
response; and Gear avoidance and disposal (1) gear conflicts estimated
at 0.2 hours per response, and (2) disposal estimated at 0.2 hours per
response.
(c) Approved under 0648-0306--Vessel identification requirements
estimated at 35 minutes per response.
(d) Approved under 0648-0305--Gear identification requirements
estimated at 30 minutes per response. Collection-of-Information
Requirements Submitted for Approval
The following collection-of-information requirements have been
submitted OMB for approval:
(a) Scientific research activity and exempted fishing--(1) 1 hour
per response to send NMFS a copy of a scientific research plan and
provide a copy of the cruise report or research publication, (2) 1 hour
per response to complete an application for an exempted fishing permit
or authorization for an exempted educational activity, and (3) 1 hour
per response to collect information and provide a report at the
conclusion of exempted fishing.
(b) Principal state officials and their designees--Estimated at 15
hours per response.
(c) Council appointments--Estimated at 120 hours per appointment
(30 appointments required).
(d) Application for reinstatement of State authority-- Estimated at
2 hours per response.
The estimated response times shown include the time for reviewing
instructions, searching existing data
[[Page 19392]]
sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding burden
estimates, or any other aspect of the data requirements, including
suggestions for reducing the burden, to NMFS and OMB (see ADDRESSES).
Notwithstanding any other provision of the law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with a collection of information, subject to the
requirements of the PRA, unless that collection of information displays
a currently valid OMB Control Number.
List of Subjects
50 CFR Parts 600, 602, and 620
Fisheries, Fishing.
50 CFR Part 601
Administrative practice and procedure, Fisheries, Fishing.
50 CFR Part 603
Confidential business information, Fisheries, Statistics.
50 CFR Part 605
Administrative practice and procedure, Fisheries, Fishing,
Reporting and recordkeeping requirements.
50 CFR Part 611
Fisheries, Foreign relations, Reporting and recordkeeping
requirements.
50 CFR Part 619
Administrative practice and procedure, Fisheries, Fishing,
Intergovernmental relations.
50 CFR Part 621
Fisheries, Fishing, Fishing vessels, Penalties.
Dated: April 17, 1996.
Gary Matlock,
Program Management Officer, National Marine Fisheries Service.
For the reasons set out in the preamble, 50 CFR parts 600, 601,
602, 603, 605, 611, 619, 620, and 621 are proposed to be amended as
follows:
1. Part 600 is revised to read as follows:
PART 600--MAGNUSON ACT PROVISIONS
Subpart A--General
Sec.
600.5 Purpose and scope.
600.10 Definitions.
600.15 Other acronyms.
Subpart B--Regional Fishery Management Councils
600.105 Intercouncil boundaries.
600.110 Intercouncil fisheries.
600.115 Statement of organization, practices, and procedures
(SOPP).
600.120 Employment practices.
600.125 Budgeting, funding, and accounting.
600.130 Protection of confidentiality of statistics.
Subpart C--Council Membership
600.205 Principal state officials and their designees.
600.210 Terms of council members.
600.215 Appointments.
600.220 Oath of office.
600.225 Rules of conduct.
600.230 Removal.
600.235 Financial disclosure.
600.240 Security assurances.
600.245 Council member compensation.
Subpart D--National Standards
600.305 General.
600.310 National Standard 1--Optimum Yield.
600.315 National Standard 2--Scientific Information.
600.320 National Standard 3--Management Units.
600.325 National Standard 4--Allocations.
600.330 National Standard 5--Efficiency.
600.335 National Standard 6--Variations and Contingencies.
600.340 National standard 7--Costs and Benefits.
Subpart E--Confidentiality of Statistics
600.405 Types of statistics covered.
600.410 Collection and maintenance of statistics.
600.415 Access to statistics.
600.420 Control system.
600.425 Release of statistics.
Subpart F--Foreign Fishing
600.501 Vessel permits.
600.502 Vessel reports.
600.503 Vessel and gear identification.
600.504 Facilitation of enforcement.
600.505 Prohibitions.
600.506 Observers.
600.507 Recordkeeping.
600.508 Fishing operations.
600.509 Prohibited species.
600.510 Gear avoidance and disposal.
600.511 Fishery closure procedures.
600.512 Scientific research.
600.513 Recreational fishing.
600.514 Relation to other laws.
600.515 Interpretation of 16 U.S.C. 1857(4).
600.516 Total allowable level of foreign fishing (TALFF).
600.517 Allocations.
600.518 Fee schedule for foreign fishing.
600.520 Northwest Atlantic Ocean fishery.
600.525 Atlantic herring fishery.
Subpart G--Preempting of State Authority Under Section 306(b)
600.605 General policy.
600.610 Factual findings for Federal preemption.
600.615 Commencement of proceedings.
600.620 Rules pertaining to the hearing.
600.625 Secretary's decision.
600.630 Application for reinstatement of state authority.
Subpart H--General Provisions for Domestic Fisheries
600.705 Relation to other laws.
600.710 Permits.
600.715 Recordkeeping and reporting.
600.720 Vessel and gear identification.
600.725 General prohibitions.
600.730 Facilitation of enforcement.
600.735 Penalties.
600.740 Enforcement policy.
600.745 Scientific research activity, exempted fishing, and
exempted educational activity.
Figure 1 to Part 600--Fishing areas of the Northwest Atlantic Ocean
fisheries.
Authority: 16 U.S.C. 1801 et seq.
Subpart A--General
Sec. 600.5 Purpose and scope.
(a) This part contains general provisions governing the operation
of the eight Regional Fishery Management Councils established by the
Magnuson Act and describes the Secretary's role and responsibilities
under the Act. The Councils are institutions created by Federal law and
must conform to the uniform standards established by the Secretary in
this part.
(b) This part also governs all foreign fishing under the Magnuson
Act, prescribes procedures for the conduct of preemption hearings under
section 306(b) of the Magnuson Act, and collects the general provisions
common to all domestic fisheries governed by this chapter.
Sec. 600.10 Definitions.
Unless defined otherwise in other parts of Chapter VI, the terms in
this chapter have the following meanings:
Administrator means the Administrator of NOAA (Under Secretary of
Commerce for Oceans and Atmosphere) or a designee.
Advisory group means a Scientific and Statistical Committee (SSC),
Fishing Industry Advisory Committee (FIAC), or Advisory Panel (AP)
established by a Council under the Magnuson Act.
Agent, for the purpose of foreign fishing (subpart F), means a
person appointed and maintained within the United States who is
authorized to receive and respond to any legal process issued in the
United States to an owner and/or operator of a vessel operating under a
permit and of any other vessel of that Nation fishing subject to the
jurisdiction of the United States. Any diplomatic official accepting
such an appointment as designated agent waives diplomatic or other
immunity in connection with such process.
Aggregate or summary form means confidential data structured in
such a way that the identity of the submitter cannot be determined
either from the
[[Page 19393]]
present release of the data or in combination with other releases.
Allocated species means any species or species group allocated to a
foreign nation under Sec. 600.517 for catching by vessels of that
Nation.
Allocation means direct and deliberate distribution of the
opportunity to participate in a fishery among identifiable, discrete
user groups or individuals.
Anadromous species means species of fish that spawn in fresh or
estuarine waters of the United States and that migrate to ocean waters.
Assistant Administrator means the Assistant Administrator for
Fisheries, NOAA, or a designee.
Authorized officer means:
(1) Any commissioned, warrant, or petty officer of the U.S. Coast
Guard;
(2) Any special agent or fishery enforcement officer of NMFS;
(3) Any officer designated by the head of any Federal or state
agency that has entered into an agreement with the Secretary and the
Commandant of the U.S. Coast Guard to enforce the provisions of the
Magnuson Act; or
(4) Any U.S. Coast Guard personnel accompanying and acting under
the direction of any person described in paragraph (1) of this
definition.
Authorized species means any species or species group that a
foreign vessel is authorized to retain in a joint venture by a permit
issued under Activity Code 4 as described by Sec. 600.501(c).
Catch, take, or harvest includes, but is not limited to, any
activity that results in killing any fish or bringing any live fish on
board a vessel.
Center means one of the five NMFS Fisheries Science Centers.
Coast Guard Commander means one of the commanding officers of the
Coast Guard units specified in Table 1 of Sec. 600.502, or a designee.
Confidential statistics are those submitted as a requirement of an
FMP and that reveal the business or identity of the submitter.
Continental shelf fishery resources means the species listed under
section 3(4) of the Magnuson Act.
Council means one of the eight Regional Fishery Management Councils
established by the Magnuson Act.
Data, statistics, and information are used interchangeably.
Dealer means the person who first receives fish by way of purchase,
barter, or trade.
Designated representative means the person appointed by a foreign
nation and maintained within the United States who is responsible for
transmitting information to and submitting reports from vessels of that
Nation and establishing observer transfer arrangements for vessels in
both directed and joint venture activities.
Directed fishing, for the purpose of foreign fishing (subpart F),
means any fishing by the vessels of a foreign nation for allocations of
fish granted that Nation under Sec. 600.517.
Director means the Director of the Office of Fisheries Conservation
and Management, NMFS, F/CM, 1315 East-West Highway, Silver Spring,
Maryland 20910.
Discard means to release or return fish to the sea, whether or not
such fish are brought fully on board a fishing vessel.
Exclusive economic zone (EEZ) means the zone established by
Presidential Proclamation 5030, 3 CFR part 22, dated March 10, 1983,
and is that area adjacent to the United States which, except where
modified to accommodate international boundaries, encompasses all
waters from the seaward boundary of each of the coastal states to a
line on which each point is 200 nautical miles (370.40 km) from the
baseline from which the territorial sea of the United States is
measured.
Exempted educational activity means an activity, conducted by an
educational institution accredited by a recognized national or
international accreditation body, of limited scope and duration, that
is otherwise prohibited by part 285 or chapter VI of this title, but
that is authorized by the appropriate Director or Regional Director for
educational purposes.
Exempted or experimental fishing means fishing from a vessel of the
United States that involves activities otherwise prohibited by part 285
or chapter VI of this title, but that are authorized under an exempted
fishing permit (EFP). These regulations refer exclusively to exempted
fishing. References in part 285 of this title and elsewhere in this
chapter to experimental fishing mean exempted fishing under this part.
Fish:
(1) When used as a noun, means any finfish, mollusk, crustacean, or
parts thereof, and all other forms of marine animal and plant life
other than marine mammals and birds.
(2) When used as a verb, means to engage in ``fishing,'' as defined
below.
Fishery means:
(1) One or more stocks of fish that can be treated as a unit for
purposes of conservation and management and that are identified on the
basis of geographic, scientific, technical, recreational, or economic
characteristics, or method of catch; or
(2) Any fishing for such stocks.
Fishery management unit (FMU) means a fishery or that portion of a
fishery identified in an FMP relevant to the FMP's management
objectives. The choice of an FMU depends on the focus of the FMP's
objectives, and may be organized around biological, geographic,
economic, technical, social, or ecological perspectives.
Fishery resource means any fish, any stock of fish, any species of
fish, and any habitat of fish.
Fishing, or to fish means any activity, other than scientific
research conducted by a scientific research vessel, that involves:
(1) The catching, taking, or harvesting of fish;
(2) The attempted catching, taking, or harvesting of fish;
(3) Any other activity that can reasonably be expected to result in
the catching, taking, or harvesting of fish; or
(4) Any operations at sea in support of, or in preparation for, any
activity described in paragraph (1), (2), or (3) of this definition.
Fishing vessel means any vessel, boat, ship, or other craft that is
used for, equipped to be used for, or of a type that is normally used
for:
(1) Fishing; or
(2) Aiding or assisting one or more vessels at sea in the
performance of any activity relating to fishing, including, but not
limited to, preparation, supply, storage, refrigeration,
transportation, or processing.
Foreign fishing means fishing by a foreign fishing vessel.
Foreign fishing vessel (FFV) means any fishing vessel other than a
vessel of the United States, except those foreign vessels engaged in
recreational fishing, as defined in this section.
Gear conflict means any incident at sea involving one or more
fishing vessels:
(1) In which one fishing vessel or its gear comes into contact with
another vessel or the gear of another vessel; and
(2) That results in the loss of, or damage to, a fishing vessel,
fishing gear, or catch.
Governing International Fishery Agreement (GIFA) means an agreement
between the United States and a foreign nation or Nations under section
201(c) of the Magnuson Act.
Grants Officer means the NOAA official authorized to sign, on
behalf of the Government, the cooperative agreement providing funds to
support the Council's operations and functions.
Greenwich mean time (GMT) means the local mean time at Greenwich,
England. All times in this part are GMT unless otherwise specified.
Harass means to unreasonably interfere with an individual's work
[[Page 19394]]
performance, or to engage in conduct that creates an intimidating,
hostile, or offensive environment.
Industry means both recreational and commercial fishing, and
includes the harvesting, processing, and marketing sectors.
International radio call sign (IRCS) means the unique radio
identifier assigned a vessel by the appropriate authority of the flag
state.
Joint venture means any operation by a foreign vessel assisting
fishing by U.S. fishing vessels, including catching, scouting,
processing and/or support. (A joint venture generally entails a foreign
vessel processing fish received from U.S. fishing vessels and
conducting associated support activities.)
Magnuson Act means the Magnuson Fishery Conservation and Management
Act, as amended (16 U.S.C. 1801 et seq.), also known as MFCMA.
Official number means the documentation number issued by the USCG
or the certificate number issued by a state or by the USCG for an
undocumented vessel.
Operator, with respect to any vessel, means the master or other
individual aboard and in charge of that vessel.
Optimum yield (OY) means the amount of fish:
(1) That will provide the greatest overall benefit to the United
States, with particular reference to food production and recreational
opportunities; and
(2) That is prescribed as such on the basis of the maximum
sustainable yield from such fishery, as modified by any relevant
economic, social, or ecological factor.
Owner, with respect to any vessel, means:
(1) Any person who owns that vessel in whole or in part;
(2) Any charterer of the vessel, whether bareboat, time, or voyage;
(3) Any person who acts in the capacity of a charterer, including,
but not limited to, parties to a management agreement, operating
agreement, or any similar agreement that bestows control over the
destination, function, or operation of the vessel; or
(4) Any agent designated as such by a person described in paragraph
(1), (2), or (3) of this definition.
Plan Team means a Council working group selected from agencies,
institutions, and organizations having a role in the research and/or
management of fisheries, whose primary purpose is to assist the Council
in the preparation and/or review of FMPs, amendments, and supporting
documents for the Council, and/or SSC and AP.
Predominately means, with respect to fishing in a fishery, that
more fishing on a stock or stocks of fish covered by the FMP occurs, or
would occur in the absence of regulations, within or beyond the EEZ
than occurs in the aggregate within the boundaries of all states off
the coasts of which the fishery is conducted.
Processing, for the purpose of foreign fishing (subpart F), means
any operation by an FFV to receive fish from foreign or U.S. fishing
vessels and/or the preparation of fish, including, but not limited to,
cleaning, cooking, canning, smoking, salting, drying, or freezing,
either on the FFV's behalf or to assist other foreign or U.S. fishing
vessels.
Product recovery rate (PRR) means a ratio expressed as a percentage
of the weight of processed product divided by the round weight of fish
used to produce that amount of product.
Prohibited species, with respect to a foreign vessel, means any
species of fish that that vessel is not specifically allocated or
authorized to retain, including fish caught or received in excess of
any allocation or authorization.
Recreational fishing, with respect to a foreign vessel, means any
fishing from a foreign vessel not operated for profit and not operated
for the purpose of scientific research. It may not involve the sale,
barter, or trade of part or all of the catch (see Sec. 600.513).
Retain, retain aboard, or retain on board means to fail to return
fish to the sea after a reasonable opportunity to sort the catch.
Region mean one of five NMFS Regional Offices responsible for
administering the management and development of marine resources in the
United States in their respective geographical regions.
Regional Director (RD) means the Director of one of the five NMFS
Regions described in Table 1 of Sec. 600.502, or a designee.
Regional Program Officer means the NMFS official designated in the
terms and conditions of the grant award responsible for monitoring,
recommending, and reviewing any technical aspects of the application
for Federal assistance and the award.
Round weight means the weight of the whole fish.
Secretary means the Secretary of Commerce or a designee.
Science and Research Director means the Director of one of the five
NMFS Fisheries Science Centers described in Table 1 of Sec. 600.502 of
this part, or a designee, also known as Center Director.
Scientific cruise means the period of time during which a
scientific research vessel is operated in furtherance of a scientific
research project, beginning when the vessel leaves port to undertake
the project and ending when the vessel completes the project as
provided for in the applicable scientific research plan.
Scientific research activity, for the purposes of this part, is an
activity in furtherance of a scientific fishery investigation or study
that would meet the definition of fishing under the Magnuson Act, but
for the exemption applicable to scientific research activity conducted
from a scientific research vessel. Scientific research activity
includes, but is not limited to, sampling, collecting, observing, or
surveying the fish or fishery resources within the EEZ, at sea, on
board scientific research vessels, to increase scientific knowledge of
the fishery resources or their environment, or to test a hypothesis as
part of a planned, directed investigation or study conducted according
to methodologies generally accepted as appropriate for scientific
research. At-sea scientific fishery investigations address one or more
issues involving taxonomy, biology, physiology, behavior, disease,
aging, growth, mortality, migration, recruitment, distribution,
abundance, ecology, stock structure, bycatch, and catch estimation of
fish and shellfish (invertebrate) species considered to be a component
of the fishery resources within the EEZ. Scientific research activity
does not include the collection and retention of fish outside the scope
of the applicable research plan, or the testing of fishing gear. Data
collection designed to capture and land quantities of fish or
invertebrates for product development, market research, and/or public
display are not scientific research activities and must be permitted
under exempted fishing procedures. For foreign vessels, such data
collection activities are considered scientific research if they are
carried out in full cooperation with the United States.
Scientific research plan means a detailed, written formulation,
prepared in advance of the research, for the accomplishment of a
scientific research project. At a minimum, a sound scientific research
plan should include:
(1) A description of the nature and objectives of the project,
including the hypothesis or hypotheses to be tested;
(2) The experimental design of the project, including a description
of the methods to be used, the type and class of any vessel(s) to be
used, and a description of sampling equipment;
(3) The geographical area(s) in which the project is to be
conducted;
(4) The expected date of first appearance and final departure of
the research vessel(s) to be employed, and
[[Page 19395]]
deployment and removal of equipment, as appropriate;
(5) The quantity and species of fish to be taken and their intended
disposition, and, if significant amounts of a managed species or
species otherwise restricted by size or sex are needed, an explanation
of such need;
(6) The name, address, and telephone/telex/fax number of the
sponsoring organization and its director;
(7) The name, address, and telephone/telex/fax number, and
curriculum vitae of the person in charge of the project and, where
different, the person in charge of the research project on board the
vessel; and
(8) The identity of any vessel(s) to be used including, but not
limited to, the vessel's name, official documentation number and IRCS,
home port, and name, address, and telephone number of the owner and
master.
Scientific research vessel means a vessel owned or chartered by,
and controlled by, a foreign government agency, U.S. Government agency
(including NOAA or institutions designated as federally funded research
and development centers), U.S. state or territorial agency, university
(or other educational institution accredited by a recognized national
or international accreditation body), international treaty
organization, or scientific institution. In order for a vessel that is
owned or chartered and controlled by a foreign government to meet this
definition, the vessel must have scientific research as its exclusive
mission during the scientific cruise in question and the vessel
operations must be conducted in accordance with a scientific research
plan.
Scouting means any operation by a vessel exploring (on the behalf
of an FFV or U.S. fishing vessel) for the presence of fish by visual,
acoustic, or other means that do not involve the catching of fish.
State means each of the several states, the District of Columbia,
the Commonwealth of Puerto Rico, American Samoa, the Virgin Islands,
Guam, and any other Commonwealth, territory, or possession of the
United States.
State employee means any employee of the state agency responsible
for developing and monitoring the state's program for marine and/or
anadromous fisheries.
Statement of Organization, Practices, and Procedures (SOPP) means a
statement by each Council describing its organization, practices, and
procedures as required under section 302(f)(6) of the Magnuson Act.
Stock assessment means the process of collecting and analyzing
biological and statistical information to determine the changes in the
abundance of fishery stocks in response to fishing, and, to the extent
possible, to predict future trends of stock abundance. Stock
assessments are based on resource surveys; knowledge of the habitat
requirements, life history, and behavior of the species; the use of
environmental indices to determine impacts on stocks; and catch
statistics. Stock assessments are used as a basis to ``assess and
specify the present and probable future condition of a fishery'' (as is
required by the Magnuson Act), and are summarized in the Stock
Assessment and Fishery Evaluation or similar document.
Stock Assessment and Fishery Evaluation (SAFE) means a document or
set of documents that provides Councils with a summary of the most
recent biological condition of species in an FMU, and the social and
economic condition of the recreational and commercial fishing
industries and the fish processing industries. It summarizes, on a
periodic basis, the best available scientific information concerning
the past, present, and possible future condition of the stocks and
fisheries being managed under Federal regulation.
Substantially (affects) means, for the purpose of subpart G, with
respect to whether a state's action or omission will substantially
affect the carrying out of an FMP for a fishery, that those effects are
important or material, or considerable in degree. The effects of a
state's action or omission for purposes of this definition include
effects upon:
(1) The achievement of the FMP's goals or objectives for the
fishery;
(2) The achievement of OY from the fishery on a continuing basis;
(3) The attainment of the national standards for fishery
conservation and management (as set forth in section 301(a) of the
Magnuson Act) and compliance with other applicable law; or
(4) The enforcement of regulations implementing the FMP.
Support means any operation by a vessel assisting fishing by
foreign or U.S. vessels, including supplying water, fuel, provisions,
fish processing equipment, or other supplies to a fishing vessel.
Transship means offloading and onloading or otherwise transferring
fish or fish products and/or transporting fish or products made from
fish.
U.S. observer or observer means any person serving in the capacity
of an observer employed by NMFS, either directly or under contract, or
certified as a supplementary observer by NMFS.
Vessel of the United States or U.S. vessel means:
(1) Any vessel documented under chapter 121 of title 46, United
States Code;
(2) Any vessel numbered under chapter 123 of title 46, United
States Code, and measuring less than 5 net tons;
(3) Any vessel numbered under chapter 123 of title 46, United
States Code, and used exclusively for pleasure; or
(4) Any vessel not equipped with propulsion machinery of any kind
and used exclusively for pleasure.
Sec. 600.15 Other acronyms.
(a) Fishery management terms:
(1) ABC--acceptable biological catch
(2) DAH--estimated domestic annual harvest
(3) DAP--estimated domestic annual processing
(4) EIS--environmental impact statement
(5) EY--equilibrium yield
(6) FMP--fishery management plan
(7) JVP--joint venture processing
(8) MSY--maximum sustainable yield
(9) PMP--preliminary FMP
(10) TAC--total allowable catch
(11) TALFF--total allowable level of foreign fishing
(b) Legislation:
(1) APA--Administrative Procedure Act
(2) CZMA--Coastal Zone Management Act
(3) ESA--Endangered Species Act
(4) FACA--Federal Advisory Committee Act
(5) FOIA--Freedom of Information Act
(6) FLSA--Fair Labor Standards Act
(7) MFCMA--Magnuson Fishery Conservation and Management Act
(8) MMPA--Marine Mammal Protection Act
(9) MPRSA--Marine Protection, Research, and Sanctuaries Act
(10) NEPA--National Environmental Policy Act
(11) PA--Privacy Act
(12) PRA--Paperwork Reduction Act
(13) RFA--Regulatory Flexibility Act
(c) Federal agencies:
(1) CEQ--Council on Environmental Quality
(2) DOC--Department of Commerce
(3) DOI--Department of the Interior
(4) DOS--Department of State
(5) EPA--Environmental Protection Agency
(6) FWS--Fish and Wildlife Service
(7) GSA--General Services Administration
(8) NMFS--National Marine Fisheries Service
[[Page 19396]]
(9) NOAA--National Oceanic and Atmospheric Administration
(10) OMB--Office of Management and Budget
(11) OPM--Office of Personnel Management
(12) SBA--Small Business Administration
(13) USCG--United States Coast Guard
Subpart B--Regional Fishery Management Councils
Sec. 600.105 Intercouncil boundaries.
(a) New England and Mid-Atlantic Councils. The boundary begins at
the intersection point of Connecticut, Rhode Island, and New York at
41 deg.18'16.249'' N. lat. and 71 deg.54'28.477'' W. long. and proceeds
south 37 deg.22'32.75'' East to the point of intersection with the
outward boundary of the EEZ as specified in the Magnuson Act.
(b) Mid-Atlantic and South Atlantic Councils. The boundary begins
at the seaward boundary between the States of Virginia and North
Carolina, and proceeds due east to the point of intersection with the
outward boundary of the EEZ as specified in the Magnuson Act.
(c) South Atlantic and Gulf of Mexico Councils. The boundary
coincides with the line of demarcation between the Atlantic Ocean and
the Gulf of Mexico, which begins at the intersection of the outer
boundary of the EEZ, as specified in the Magnuson Act, and 83 deg.00'
W. long., proceeds northward along that meridian to 24 deg.35' N. lat.,
(near the Dry Tortugas Islands), thence eastward along that parallel,
through Rebecca Shoal and the Quicksand Shoal, to the Marquesas Keys,
and then through the Florida Keys to the mainland at the eastern end of
Florida Bay, the line so running that the narrow waters within the Dry
Tortugas Islands, the Marquesas Keys and the Florida Keys, and between
the Florida Keys and the mainland, are within the Gulf of Mexico.
Sec. 600.110 Intercouncil fisheries.
If any fishery extends beyond the geographical area of authority of
any one Council, the Secretary may--
(a) Designate a single Council to prepare the FMP for such fishery
and any amendments to such FMP, in consultation with the other Councils
concerned; or
(b) Require that the FMP and any amendments be prepared jointly by
all the Councils concerned.
(1) A jointly prepared FMP or amendment must be adopted by a
majority of the voting members, present and voting, of each
participating Council. Different conservation and management measures
may be developed for specific geographic areas, but the FMP should
address the entire geographic range of the stock(s).
(2) In the case of joint FMP or amendment preparation, one Council
will be designated as the ``administrative lead.'' The ``administrative
lead'' Council is responsible for the preparation of the FMP or any
amendments and other required documents for submission to the
Secretary.
(3) None of the Councils involved in joint preparation may withdraw
without Secretarial approval. If Councils cannot agree on approach or
management measures within a reasonable period of time, the Secretary
may designate a single Council to prepare the FMP or may issue the FMP
under Secretarial authority.
Sec. 600.115 Statement of organization, practices, and procedures
(SOPP).
(a) Councils are required to publish and make available to the
public a SOPP in accordance with such uniform standards as are
prescribed by the Secretary (section 302(f)(6)) of the Magnuson Act.
The purpose of the SOPP is to inform the public how the Council
operates within the framework of the Secretary's uniform standards.
(b) Amendments to current SOPPs must be consistent with the
guidelines in this section and the terms and conditions of the
cooperative agreement, the statutory requirements of the Magnuson Act
and other applicable law. Upon approval of a Council's SOPP amendment
by the Secretary, a Notice of Availability will be published in the
Federal Register, including an address where the public may write to
request copies.
(c) Councils may deviate, where lawful, from the guidelines with
appropriate supporting rationale, and Secretarial approval of each
amendment to a SOPP would constitute approval of any such deviations
for that particular Council.
Sec. 600.120 Employment practices.
Council members (except for Federal Government officials) and staff
are not Federal employees subject to OPM regulations. Council staffing
practices are set forth in each Council's SOPP.
Sec. 600.125 Budgeting, funding, and accounting.
Each Council's activities are governed by OMB Circular A-110
(Uniform Administrative Requirements for Grants and Agreements with
Institutions of Higher Education, Hospitals, and other Non-Profit
Organizations), OMB Circular A-122 (Cost Principles for Non-Profit
Organizations), 15 CFR Part 29b (Audit Requirements for Institutions of
Higher Education and Other Nonprofit Organizations), and the terms and
conditions of the cooperative agreement.
Sec. 600.130 Protection of confidentiality of statistics.
Each Council must establish appropriate procedures for ensuring the
confidentiality of the statistics that may be submitted to it by
Federal or state authorities and may be voluntarily submitted to it by
private persons, including, but not limited to:
(a) Procedures for the restriction of Council member, employee, or
advisory group access and the prevention of conflicts of interest,
except that such procedures must be consistent with procedures of the
Secretary; and
(b) In the case of statistics submitted to the Council by a state,
the confidentiality laws and regulations of that state.
Subpart C--Council Membership
Sec. 600.205 Principal state officials and their designees.
(a) Only a full-time state employee of the state agency responsible
for marine and/or anadromous fisheries shall be designated by a
constituent state Governor as the principal state official for purposes
of section 302(b) of the Magnuson Act. New or revised designations by
state Governors of principal state officials, and new or revised
designations by principal state officials of their designees(s), must
be delivered in writing to the appropriate NMFS Regional Director at
least 48 hours before the individual may vote on any issue before the
Council. Written designation(s) must indicate the employment status of
each principal state official and that of his/her designee(s); how the
official or designee is employed by the state fisheries agency; where
each individual is employed (business address and telephone number);
and whether the official's full salary is paid by the state.
(b) A principal state official may name his/her designee(s) to act
on his/her behalf at Council meetings. Individuals designated to serve
as designees of a principal state official on a Council, pursuant to
section 302(b)(1)(A) of the Magnuson Act, must be subordinates of the
principal state official involved in the development of fisheries
management policies for that state.
Sec. 600.210 Terms of Council members.
(a) Voting members (other than principal state officials, the
Regional Directors, or their designees) are
[[Page 19397]]
appointed for a term of 3 years and, except as discussed below, may be
reappointed. A voting member's Council service during any portion of a
3-year term of office (i.e., 1 day or more) will be counted as service
for the entire 3-year term of office. In addition, an individual
appointed to fill a vacancy occurring prior to the expiration of any
term of office will be appointed for the remainder of that term, and
that member will be considered to have served the entire term when the
remainder of that term is completed.
(b) The anniversary date for measuring terms of membership is
August 11. The Secretary may designate a term of appointment shorter
than 3 years, if necessary, to provide for balanced expiration of terms
of office. Members may not serve more than three consecutive terms.
(c) A member appointed after January 1, 1986, who has completed
three consecutive terms will not be eligible for appointment to another
term on any Council until one year has elapsed since the last day of
that member's service.
Sec. 600.215 Appointments.
The following procedures govern the nomination and appointment of
Council members.
(a) Each year, terms of approximately one-third of the appointed
members of each Council expire. New members will be appointed, or
seated members will be reappointed to another term, by the Secretary to
fill the seats being vacated. The Secretary will select the appointees
from lists of nominees submitted by March 15 of each year by the
Governors of the constituent states that are eligible to nominate
candidates for that vacancy. When an appointed member vacates his/her
seat prior to the expiration of his/her term, the Secretary will fill
the vacancy for the remainder of the term by selecting from among the
nominees submitted by the responsible Governor(s).
(b) A Governor must submit the names of at least three qualified
nominees for each applicable vacancy.
(c) Governors are responsible for ensuring that persons nominated
for appointment meet the qualification requirements of the Magnuson
Act. A Governor must provide a statement explaining how each of his or
her nominees meets the qualification requirements; and must provide
appropriate documentation to the Secretary that each nomination was
made in consultation with commercial and recreational fishing interests
of that state, and that each nominee is knowledgeable and experienced,
by reason of his or her occupational or other experience, scientific
expertise, or training, in one or more of the following ways related to
the fishery resources of the geographical area of concern to the
Council:
(1) Commercial fishing or the processing or marketing of fish, fish
products, or fishing equipment;
(2) Fishing for pleasure, relaxation, or consumption, or experience
in any business supporting fishing;
(3) Leadership in a state, regional, or national organization whose
members participate in a fishery in the Council's area of authority;
(4) The management and conservation of natural resources, including
related interactions with industry, government bodies, academic
institutions, and public agencies. This includes experience serving as
a member of a Council, AP, SSC, or FIAC;
(5) Representing consumers of fish or fish products through
participation in local, state, or national organizations, or performing
other activities specifically related to the education or protection of
consumers of marine resources; and
(6) Teaching, journalism, writing, consulting, legal practice, or
researching matters related to fisheries, fishery management, and
marine resource conservation.
(d) To assist in identifying necessary qualifications, each nominee
must furnish to the appropriate Governor's office a current resume, or
equivalent, describing career history--with particular attention to
experience related to the above criteria. Nominees may provide such
information in any format they wish. Career and educational history
information sent to the Governors should also be sent to the NMFS
Office of Fisheries Conservation and Management.
(e) The Secretary will review each list submitted by a Governor to
ascertain if the individuals on the list are qualified for the vacancy
on the basis of the criteria prescribed in paragraph (c) of this
section. If the Secretary determines that any nominee is not qualified,
the Secretary will notify the appropriate Governor of that
determination. The Governor shall then submit a revised list or
resubmit the original list with an additional explanation of the
qualifications of the nominee in question. The Secretary reserves the
right to determine whether nominees are qualified.
(f) There are two categories of seats to which voting members are
appointed: ``obligatory'' and ``at-large.''
(1) Each constituent state is entitled to one seat on the Council
on which it is a member, except that Alaska is entitled to five seats
and Washington is entitled to two seats on the North Pacific Fishery
Management Council. When the term of a state's obligatory member is
expiring, or that seat becomes vacant before the expiration of its
term, the Governor of that state must submit the names of at least
three qualified individuals to fill that seat. In order to fill a
state's obligatory seat, the Secretary may select from any of the
nominees for such obligatory seat and from the nominees for any at-
large seat submitted by the Governor of that state. If a Governor fails
to provide a list of at least three qualified nominees for a seat
obligated to that Governor's state, then the state's obligatory seat
will remain vacant until three qualified nominees are submitted by the
Governor and acted upon by the Secretary.
(2) Prior to submitting nominees for appointment to a Council, a
constituent state Governor must determine if each of his or her
nominees is a resident of that constituent state. A State Governor may
not nominate a non-resident of that state for appointment to a Council
seat obligated to that state. If, at any time during a term, an
appointee to an obligatory seat changes residency to another state that
is not a constituent state of that Council, the member may no longer
vote as a representative of that state and must resign from that
obligated seat. For purposes of this paragraph (f)(2), a state resident
is an individual who maintains his/her principal residence within that
constituent state and, if applicable, pays income taxes to that state
and/or to another appropriate jurisdiction within that state.
(g) When the term of an at-large member is expiring, or that seat
becomes vacant before the expiration of a term, the Governors of all
constituent states of that Council must each submit the names of at
least three qualified individuals to fill that seat.
(1) In order to fill an at-large seat, the Secretary may select a
nominee for that seat submitted by any Governor of a constituent state.
When the terms of both an obligatory member and an at-large member
expire concurrently, the Governor of the state holding the expiring
obligatory seat may indicate that the nominees who were not selected
for appointment to the obligatory seat may be considered for
appointment to an at-large seat, provided that the resulting total
number of nominees submitted by that Governor for the expiring at-large
seat is no fewer than three.
(2) If a Governor fails to submit a list of three qualified
nominees for an available at-large seat within the time allotted, then
a new at-large member
[[Page 19398]]
will be appointed from lists of qualified nominees submitted by
Governors of other constituent states.
(3) If a Governor chooses to submit nominations for one or more
vacant at-large seats on a Council, he/she must submit lists such that
at least three different nominees will be available to be considered
for each vacant seat.
(4) In filling expiring at-large seats, the Secretary will consider
only complete slates of nominees submitted by the Governors of the
Council's constituent states. If nominations are requested to fill more
than one at-large seat and a Governor elects to nominate a total of
four candidates, i.e., a slate of three candidates for one seat and one
for the other(s), the set of three candidates will be considered only
for the first seat, but the two candidates who were not selected will
not be considered for the other(s). In this case, the only candidates
considered for the other seat(s) would be derived from the slates
offered by the Governors of the other states that included three
different qualified candidates, i.e., candidates who were not
considered for one of the other seats.
(5) Governors may nominate residents of another constituent state
of a Council for appointment to an at-large seat on that Council.
(6) The Secretary must, to the extent practicable, ensure a fair
and balanced apportionment, on a rotating or other basis, of the active
participants (or their representatives) in the commercial and
recreational fisheries in the Council's area of authority. Further, the
Secretary must take action to ensure, to the extent practicable, that
those persons dependent for their livelihood upon the fisheries in the
Council's area of authority are fairly represented as voting members.
Sec. 600.220 Oath of office.
Each member appointed to a Council must take an oath of office.
Sec. 600.225 Rules of conduct.
(a) Council members, as Federal office holders, and Council
employees are subject to most Federal criminal statutes covering
bribery, conflict-of-interest, disclosure of confidential information,
and lobbying with appropriated funds.
(b) The Councils are responsible for maintaining high standards of
ethical conduct among themselves, their staffs, and their advisory
groups. In addition to abiding by the applicable Federal conflict of
interest statutes, both members and employees of the Councils must
comply with the following standards of conduct:
(1) No employee of a Council may use his or her official authority
or influence derived from his or her position with the Council for the
purpose of interfering with or affecting the result of an election to
or a nomination for any national, state, county, or municipal elective
office.
(2) No employee of a Council may be deprived of employment,
position, work, compensation, or benefit provided for or made possible
by the Magnuson Act on account of any political activity or lack of
such activity in support of or in opposition to any candidate or any
political party in any national, state, county, or municipal election,
or on account of his or her political affiliation.
(3) No Council member or employee may pay, offer, promise, solicit,
or receive from any person, firm, or corporation a contribution of
money or anything of value in consideration of either support or the
use of influence or the promise of support or influence in obtaining
for any person any appointive office, place, or employment under the
Council.
(4) No employee of a Council may have a direct or indirect
financial interest that conflicts with the fair and impartial conduct
of his or her Council duties. However, an Executive Director may retain
a financial interest in harvesting, processing or marketing activities,
and participate in matters of general public concern on the Council
that might affect that interest, if that interest has been disclosed in
a report filed under Sec. 600.230.
(5) No Council member, employee of a Council, or member of a
Council advisory group may use or allow the use, for other than
official purposes, of information obtained through or in connection
with his or her Council employment that has not been made available to
the general public.
(6) No Council member or employee of the Council may engage in
criminal, infamous, dishonest, notoriously immoral, or disgraceful
conduct.
(7) No Council member or employee of the Council may use Council
property on other than official business. Such property must be
protected and preserved from improper or deleterious operation or use.
(8) No Council member may participate--
(i) Personally and substantially as a member through decision,
approval, disapproval, recommendation, the rendering of advice,
investigation, or otherwise in a particular matter primarily of
individual concern, such as a contract, in which he or she has a
financial interest; or
(ii) In any matter of general public concern that is likely to have
a direct and predictable effect on a member's financial interest,
unless that interest is in harvesting, processing, or marketing
activities and has been disclosed in a report filed under Sec. 600.230.
For purposes of this section, the member's financial interest includes
that of the member's spouse; minor child; partner; organization in
which the member is serving as officer, director, trustee, partner or
employee; or any person or organization with whom the member is
negotiating or has any arrangement concerning prospective employment.
Sec. 600.230 Removal.
The Secretary may remove for cause any Secretarially appointed
member of a Council in accordance with section 302(b)(5) of the
Magnuson Act, wherein the Council concerned first recommends removal of
that member by not less than two-thirds of the voting members. A
recommendation of a Council to remove a member must be made in writing
to the Secretary and accompanied by a statement of the reasons upon
which the recommendation is based.
Sec. 600.235 Financial disclosure.
(a) The Magnuson Act requires the disclosure by each Council
nominee, voting member appointed to the Council by the Secretary, and
Executive Director, of any financial interest of the reporting
individual in any harvesting, processing, or marketing activity that is
being, or will be, undertaken within any fishery under the authority of
the individual's Council, and of any such financial interest of the
reporting individual's spouse, minor child, partner, or any
organization (other than the Council) in which that individual is
serving as an officer, director, trustee, partner, or employee. The
information required to be reported must be disclosed on NOAA Form 88-
195, ``Statement of Financial Interests for Use by Voting Members,
Nominees, and Executive Directors of Regional Fishery Management
Councils'' (Financial Interest Form), or such other form as the
Secretary may prescribe. The report must be filed by each nominee for
Secretarial appointment with the Assistant Administrator by April 15
or, if nominated after March 15, 1 month after nomination by the
Governor. A seated voting member appointed by the Secretary, or an
Executive Director, must file a Financial Interest Form within 45 days
of taking office; must update his/her statement within 30 days of
acquiring any such financial interest, or of substantially changing a
financial interest; and must update his/her
[[Page 19399]]
statement annually and file that update by February 1 of each year with
the Executive Director of the appropriate Council, and concurrently
provide copies of such documents to the NMFS Regional Director for the
geographic area concerned. The completed Financial Interest Forms will
be kept on file, and made available for public inspection at reasonable
hours at the Council offices. In addition, the statements will be made
available at each public Council meeting or hearing.
(b) The provisions of 18 U.S.C. 208 do not apply to an individual
who has filed a financial report under this section regarding an
interest that has been reported.
(c) By February 1 of each year, Councils must forward copies of the
completed disclosure from each current Council member and Executive
Director to the Director, Office of Fisheries Conservation and
Management, NMFS. Councils must also include any updates in
disclosures, as well as revisions required for changes of interests.
(d) Councils must retain the disclosure forms for each member for
at least 5 years after the expiration of that member's last term.
Sec. 600.240 Security assurances.
(a) DOC/OS will issue security assurances to Council nominees and
members following completion of background checks. Security assurances
will be valid for 5 years from the date of issuance. A security
assurance will not entitle the member to access classified data. In
instances in which Council members may need to discuss, at closed
meetings, materials classified for national security purposes, the
agency or individual (e.g., DOS, USCG) providing such classified
information will be responsible for ensuring that Council members and
other attendees have the appropriate security clearances.
(b) Each nominee to a Council is required to complete a
Certification of Status form (``form''). All nominees must certify,
pursuant to the Foreign Agents Registration Act of 1938, whether they
serve as an agent of a foreign principal. Each nominee must certify,
date, sign, and return the form with his/her completed nomination kit.
Nominees will not be considered for appointment to a Council if they
have not filed this form. Any nominee who currently is an agent of a
foreign principal will not be eligible for appointment to a Council,
and therefore should not be nominated by a Governor for appointment.
Sec. 600.245 Council member compensation.
(a) The obligatory and at-large voting members of each Council
appointed under section 302(b)(1)(C) of the Magnuson Act who are not
employed by the Federal Government or any state or local government
(i.e., any member who does not receive compensation from any such
government for the period when performing duties as a Council member)
shall receive compensation at 1.2 times the daily rate for a GS-15
(Step 1) of the General Schedule (without locality pay) when engaged in
actual performance of duties as assigned by the Chair of the Council.
Actual performance of duties, for the purposes of compensation, may
include travel time.
(b) All voting Council members whose eligibility for compensation
has been established in accordance with NOAA guidelines will be paid
through the cooperative agreement as a direct line item on a
contractual basis without deductions being made for Social Security or
Federal and state income taxes. A report of compensation will be
furnished each year by the member's Council to the proper Regional
Program Officer, as required by the Internal Revenue Service. Such
compensation may be paid on a full day's basis, whether in excess of 8
hours a day or less than 8 hours a day. The time is compensable where
the individual member is required to expend a significant private
effort that substantially disrupts the daily routine to the extent that
a work day is lost to the member. ``Homework'' time in preparation for
formal Council meetings is not compensable.
(c) Non-government Council members receive compensation for:
(1) Days spent in actual attendance at a meeting of the Council or
jointly with another Council.
(2) Travel on the day preceding or following a scheduled meeting
that precluded the member from conducting his normal business on the
day in question.
(3) Meetings of standing committees of the Council if approved in
advance by the Chair.
(4) Individual member meeting with scientific and technical
advisors, when approved in advance by the Chair and a substantial
portion of any day is spent at the meeting.
(5) Conducting or attending hearings, when authorized in advance by
the Chair.
(6) Other meetings involving Council business when approved in
advance by the Chair.
(d) The Executive Director of each Council must submit to the
appropriate Regional Office annually a report, approved by the Council
Chair, of Council member compensation authorized. This report shall
identify, for each member, amount paid, dates, and location and purpose
of meetings attended.
Subpart D--National Standards
Sec. 600.305 General.
(a) Purpose--(1) This subpart establishes guidelines, based on the
national standards, to assist in the development and review of FMPs,
amendments, and regulations prepared by the Councils and the Secretary.
(2) In developing FMPs, the Councils have the initial authority to
ascertain factual circumstances, to establish management objectives,
and to propose management measures that will achieve the objectives.
The Secretary will determine whether the proposed management objectives
and measures are consistent with the national standards, other
provisions of the Magnuson Act, and other applicable law. The Secretary
has an obligation under section 301(b) of the Magnuson Act to inform
the Councils of the Secretary's interpretation of the national
standards so that they will have an understanding of the basis on which
FMPs will be reviewed.
(3) The national standards are statutory principles that must be
followed in any FMP. The guidelines summarize Secretarial
interpretations that have been, and will be, applied under these
principles. The guidelines are intended as aids to decisionmaking; FMPs
formulated according to the guidelines will have a better chance for
expeditious Secretarial review, approval, and implementation. FMPs that
are in substantial compliance with the guidelines, the Magnuson Act,
and other applicable law must be approved.
(b) Fishery management objectives. (1) Each FMP, whether prepared
by a Council or by the Secretary, should identify what the FMP is
designed to accomplish, i.e., the management objectives to be attained
in regulating the fishery under consideration. In establishing
objectives, Councils balance biological constraints with human needs,
reconcile present and future costs and benefits, and integrate the
diversity of public and private interests. If objectives are in
conflict, priorities should be established among them.
(2) How objectives are defined is important to the management
process. Objectives should address the problems of a particular
fishery. The objectives should be clearly stated, practicably
attainable, framed in terms of definable
[[Page 19400]]
events and measurable benefits, and based upon a comprehensive rather
than a fragmentary approach to the problems addressed. An FMP should
make a clear distinction between objectives and the management measures
chosen to achieve them. The objectives of each FMP provide the context
within which the Secretary will judge the consistency of an FMP's
conservation and management measures with the national standards.
(c) Word usage. The word usage refers to all regulations in this
subpart.
(1) Must is used, instead of ``shall'', to denote an obligation to
act; it is used primarily when referring to requirements of the
Magnuson Act, the logical extension thereof, or of other applicable
law.
(2) Shall is used only when quoting statutory language directly, to
avoid confusion with the future tense.
(3) Should is used to indicate that an action or consideration is
strongly recommended to fulfill the Secretary's interpretation of the
Magnuson Act, and is a factor reviewers will look for in evaluating a
SOPP or FMP.
(4) May is used in a permissive sense.
(5) May not is proscriptive; it has the same force as ``must not.''
(6) Will is used descriptively, as distinguished from denoting an
obligation to act or the future tense.
(7) Could is used when giving examples, in a hypothetical,
permissive sense.
(8) Can is used to mean ``is able to,'' as distinguished from
``may.''
(9) Examples are given by way of illustration and further
explanation. They are not inclusive lists; they do not limit options.
(10) Analysis, as a paragraph heading, signals more detailed
guidance as to the type of discussion and examination an FMP should
contain to demonstrate compliance with the standard in question.
(11) Determine is used when referring to OY.
(12) Adjust is used when establishing a deviation from MSY for
biological reasons, such as in establishing ABC, TAC, or EY.
(13) Modify is used when the deviati
FR Doc. 96-9988 Magnuson Act Provisions; Consolidation and Update of Regulations
on from MSY is for the purpose
of determining OY, in accord with relevant economic, social, or
ecological factors.
Sec. 600.310 National Standard 1--Optimum Yield.
(a) Standard 1. Conservation and management measures shall prevent
overfishing while achieving, on a continuing basis, the OY from each
fishery for the U.S. fishing industry.
(b) General. The determination of OY is a decisional mechanism for
resolving the Magnuson Act's multiple purposes and policies, for
implementing an FMP's objectives, and for balancing the various
interests that comprise the national welfare. OY is based on MSY, or on
MSY as it may be adjusted under paragraph (d)(3) of this section. The
most important limitation on the specification of OY is that the choice
of OY--and the conservation and management measures proposed to achieve
it--must prevent overfishing.
(c) Overfishing. (1) Overfishing is a level or rate of fishing
mortality that jeopardizes the long-term capacity of a stock or stock
complex to produce MSY on a continuing basis. Each FMP must specify, to
the maximum extent possible, an objective and measurable definition of
overfishing for each stock or stock complex covered by that FMP, and
provide an analysis of how the definition was determined and how it
relates to reproductive potential.
(2) The definition of overfishing for a stock or stock complex may
be developed or expressed in terms of a minimum level of spawning
biomass (``threshold''); maximum level or rate of fishing mortality; or
formula, model, or other measurable standard designed to ensure the
maintenance of the stock's productive capacity. Overfishing must be
defined in a way to enable the Council and the Secretary to monitor and
evaluate the condition of the stock or stock complex relative to the
definition.
(3) Different fishing patterns can produce a variety of effects on
local and areawide abundance, availability, size, and age composition
of a stock. Some of these fishing patterns have been called ``growth,''
``localized,'' or ``pulse'' overfishing; however, these patterns are
not necessarily overfishing under the national standard 1 definition,
which focuses on recruitment and long-term reproductive capacity. (Also
see paragraph (c)(6)(v)).
(4) Overfishing definitions must be based on the best scientific
information available. Councils must build into the definition
appropriate consideration of risk, taking into account uncertainties in
estimating domestic harvest, stock conditions, or the effects of
environmental factors (also see Sec. 600.335). In cases where
scientific data are severely limited, the Councils' informed judgment
must be used, and effort should be directed to identifying and
gathering the needed data.
(5) Secretarial approval or disapproval of the overfishing
definition will be based on consideration of whether the proposal:
(i) Has sufficient scientific merit;
(ii) Is likely to result in effective Council action to prevent the
stock from closely approaching or reaching an overfished status;
(iii) Provides a basis for objective measurement of the status of
the stock against the definition; and
(iv) Is operationally feasible.
(6) In addition to a specific definition of overfishing for each
stock or stock complex, an FMP must contain management measures
necessary to prevent overfishing.
(i) If overfishing is defined in terms of a threshold biomass
level, the Council must ensure that fishing effort does not cause
spawning biomass to fall and remain below that threshold.
(ii) If overfishing is defined in terms of a maximum fishing
mortality rate, the Council must ensure that fishing effort on that
stock does not cause the maximum rate to be exceeded.
(iii) If data indicate that an overfished condition exists, a
program must be established for rebuilding the stock over a period of
time specified by the Council and acceptable to the Secretary.
(iv) If data indicate that a stock or stock complex is approaching
an overfished condition, the Council should identify actions or
combination of actions to be undertaken in response.
(v) Depending on the objectives of a particular FMP and the
specific definition of overfishing established for the stock or stock
complex under management, a Council may recommend measures to prevent
or permit pulse, localized, or growth overfishing.
(7) Significant adverse alterations in environment/habitat
conditions increase the possibility that fishing effort will contribute
to a stock collapse. Care should be taken to identify the cause of any
downward trends in spawning stock sizes or average annual recruitment.
(i) Whether these trends are caused by environmental changes or by
fishing effort, the only direct control provided by the Magnuson Act is
to reduce fishing mortality.
(ii) Unless the Council asserts, as supported by appropriate
evidence, that reduced fishing effort would not alleviate the problem,
the FMP must include measures to reduce fishing mortality, regardless
of the cause of the low population level.
(iii) If manmade environmental changes are contributing to the
downward trends, in addition to controlling effort, Councils should
recommend restoration of habitat and other ameliorative programs, to
the extent possible, and consider whether to
[[Page 19401]]
take action under section 302(i) of the Magnuson Act.
(8) There are certain limited exceptions to the requirement to
prevent overfishing. Harvesting the major component of a mixed fishery
at its optimum level may result in the overfishing of a minor (smaller
or less valuable) stock component in the fishery. A Council may decide
to permit this type of overfishing if it is demonstrated by analysis
(paragraph (f)(5) of this section) that it will result in net benefits
to the Nation, and if the Council's action will not cause any stock to
require protection under the ESA.
(9) All FMPs should contain a definition of overfishing for the
stock or stock complex managed under the affected FMP.
(d) MSY. (1) MSY is the largest average annual catch or yield that
can be taken over a significant period of time from each stock under
prevailing ecological and environmental conditions.
(2) MSY may be presented as a range of values. One MSY may be
specified for a related group of species in a mixed-species fishery.
Since MSY is a long-term average, it need not be specified annually,
but must be based on the best scientific information available.
(3) MSY may be only the starting point in providing a realistic
biological description of allowable fishery removals. MSY may need to
be adjusted because of environmental factors, stock peculiarities, or
other biological variables, prior to the determination of OY. An
example of such an adjustment is determination of ABC.
(e) ABC. (1) ABC is a preliminary description of the acceptable
harvest (or range of harvests) for a given stock or stock complex. Its
derivation focuses on the status and dynamics of the stock,
environmental conditions, other ecological factors, and prevailing
technological characteristics of the fishery.
(2) When ABC is used, its specification constitutes the first step
in deriving OY from MSY. Unless the best scientific information
available indicates otherwise (see Sec. 600.315, ABC should be no
higher than the product of the stock's natural mortality rate and the
biomass of the exploitable stock. If a threshold has been specified for
the stock, ABC must equal zero when the stock is at or below that
threshold (also see paragraph (c)(2) of this section). ABC may be
expressed in numeric or nonnumeric terms.
(f) OY--(1) Definition. The term ``optimum'' with respect to the
yield from a fishery, means the amount of fish that will provide the
greatest overall benefit to the Nation, with particular reference to
food production and recreational opportunities; and that is prescribed
as such on the basis of the MSY from each fishery, as modified by any
relevant economic, social, or ecological factors (section 3(21)(b) of
the Magnuson Act).
(2) Values in determination. In determining the greatest benefit to
the Nation, two values that should be weighed are food production and
recreational opportunities (section 3(21)(a) of the Magnuson Act). They
should receive serious attention as measures of benefit when
considering the economic, ecological, or social factors used in
modifying MSY to obtain OY.
(i) Food production encompasses the goals of providing seafood to
consumers, maintaining an economically viable fishery, and utilizing
the capacity of U.S. fishery resources to meet nutritional needs.
(ii) Recreational opportunities includes recognition of the
importance of the quality of the recreational fishing experience, and
of the contribution of recreational fishing to the national, regional,
and local economies and food supplies.
(3) Factors relevant to OY. The Magnuson Act's definition of OY
identifies three categories of factors to be used in modifying MSY to
arrive at OY: Economic, social, and ecological (section 3(21)(b) of the
Magnuson Act). Not every factor will be relevant in every fishery. For
some fisheries, insufficient information may be available with respect
to some factors to provide a basis for corresponding modifications to
MSY.
(i) Economic factors. Examples are promotion of domestic fishing,
development of unutilized or underutilized fisheries, satisfaction of
consumer and recreational needs, and encouragement of domestic and
export markets for U.S.-harvested fish. Some other factors that may be
considered are the value of fisheries, the level of capitalization,
operating costs of vessels, alternate employment opportunities, and
economies of coastal areas.
(ii) Social factors. Examples are enjoyment gained from
recreational fishing, avoidance of gear conflicts and resulting
disputes, preservation of a way of life for fishermen and their
families, and dependence of local communities on a fishery. Among other
factors that may be considered are the cultural place of subsistence
fishing, obligations under Indian treaties, and worldwide nutritional
needs.
(iii) Ecological factors. Examples are the vulnerability of
incidental or unregulated species in a mixed-species fishery, predator-
prey or competitive interactions, and dependence of marine mammals and
birds or endangered species on a stock of fish. Equally important are
environmental conditions that stress marine organisms, such as natural
and manmade changes in wetlands or nursery grounds, and effects of
pollutants on habitat and stocks.
(4) Specification. (i) The amount of fish that constitutes the OY
need not be expressed in terms of numbers or weight of fish. The
economic, social, or ecological modifications to MSY may be expressed
by describing fish having common characteristics, the harvest of which
provides the greatest overall benefit to the Nation. For instance, OY
may be expressed as a formula that converts periodic stock assessments
into quotas or guideline harvest levels for recreational, commercial,
and other fishing. OY may be defined in terms of an annual harvest of
fish or shellfish having a minimum weight, length, or other
measurement. OY may also be expressed as an amount of fish taken only
in certain areas, or in certain seasons, or with particular gear, or by
a specified amount of fishing effort. In the case of a mixed-species
fishery, the incidental-species OY may be a function of the directed
catch, or absorbed into an OY for related species.
(ii) If a numerical OY is chosen, a range or average may be
specified.
(iii) In a fishery where there is a significant discard component,
the OY may either include or exclude discards, consistent with the
other yield determinations.
(iv) The OY specification can be converted into an annual numerical
estimate to establish any TALFF and to analyze impacts of the
management regime. There should be a mechanism in an FMP for periodic
reassessment of the OY specification, so that it is responsive to
changing circumstances in the fishery.
(v) The determination of OY requires a specification of MSY.
However, even where sufficient scientific data as to the biological
characteristics of the stock do not exist, or the period of
exploitation or investigation has not been long enough for adequate
understanding of stock dynamics, or where frequent large-scale
fluctuations in stock size make this concept of limited value, the OY
should be based on the best scientific information available.
(5) Analysis. An FMP must contain an analysis of how its OY
specification was determined (section 303(a)(3) of the Magnuson Act).
It should relate the
[[Page 19402]]
explanation of overfishing in paragraph (c) of this section to
conditions in the particular fishery, and explain how its choice of OY
and conservation and management measures will prevent overfishing in
that fishery. If overfishing is permitted under paragraph (c)(8) of
this section, the analysis must contain a justification in terms of
overall benefits and an assessment of the risk of the species or stock
component reaching a threatened or endangered status. A Council must
identify those economic, social, and ecological factors relevant to
management of a particular fishery, then evaluate them to arrive at the
modification (if any) of MSY. The choice of a particular OY must be
carefully defined and documented to show that the OY selected will
produce the greatest benefit to the Nation.
(g) OY as a target. (1) The specification of OY in an FMP is not
automatically a quota or ceiling, although quotas may be derived from
the OY, where appropriate. OY is a target or goal; an FMP must contain
conservation and management measures, and provisions for information
collection, that are designed to achieve OY. These measures should
allow for practical and effective implementation and enforcement of the
management regime, so that the harvest is allowed to reach, but not to
exceed OY by a substantial amount. The Secretary has an obligation to
implement and enforce the FMP so that OY is achieved. If management
measures prove unenforceable--or too restrictive, or not rigorous
enough to realize OY--they should be modified; an alternative is to
reexamine the adequacy of the OY specification.
(2) Exceeding OY does not necessarily constitute overfishing,
although they might coincide. Even if no overfishing resulted,
continual harvest at a level above a fixed-value OY would violate
National Standard 1, because OY was exceeded (not achieved) on a
continuing basis.
(3) Part of the OY may be held as a reserve to allow for
uncertainties in estimates of stock size and of DAH or to solve
operational problems in achieving (but not exceeding) OY. If an OY
reserve is established, an adequate mechanism should be included in the
FMP to permit timely release of the reserve to domestic or foreign
fishermen, if necessary.
(h) OY and foreign fishing. Section 201(d) of the Magnuson Act
provides that fishing by foreign nations is limited to that portion of
the OY that will not be harvested by vessels of the United States.
(1) DAH. Councils must consider the capacity of, and the extent to
which, U.S. vessels will harvest the OY on an annual basis. Estimating
the amount that U.S. fishing vessels will actually harvest is required
to determine the surplus.
(2) DAP. Each FMP must identify the capacity of U.S. processors. It
must also identify the amount of DAP, which is the sum of two
estimates:
(i) The amount of U.S. harvest that domestic processors will
process. This estimate may be based on historical performance and on
surveys of the expressed intention of manufacturers to process,
supported by evidence of contracts, plant expansion, or other relevant
information; and
(ii) The amount of fish that will be harvested by domestic vessels,
but not processed (e.g., marketed as fresh whole fish, used for private
consumption, or used for bait).
(iii) JVP. When DAH exceeds DAP, the surplus is available for JVP.
JVP is derived from DAH.
Sec. 600.315 National Standard 2--Scientific Information.
(a) Standard 2. Conservation and management measures shall be based
upon the best scientific information available.
(b) FMP development. The fact that scientific information
concerning a fishery is incomplete does not prevent the preparation and
implementation of an FMP (see related Secs. 600.320(d)(2) and
600.340(b).
(1) Scientific information includes, but is not limited to,
information of a biological, ecological, economic, or social nature.
Successful fishery management depends, in part, on the timely
availability, quality, and quantity of scientific information, as well
as on the thorough analysis of this information, and the extent to
which the information is applied. If there are conflicting facts or
opinions relevant to a particular point, a Council may choose among
them, but should justify the choice.
(2) FMPs must take into account the best scientific information
available at the time of preparation. Between the initial drafting of
an FMP and its submission for final review, new information often
becomes available. This new information should be incorporated into the
final FMP where practicable; but it is unnecessary to start the FMP
process over again, unless the information indicates that drastic
changes have occurred in the fishery that might require revision of the
management objectives or measures.
(c) FMP implementation. (1) An FMP must specify whatever
information fishermen and processors will be required or requested to
submit to the Secretary. Information about harvest within state
boundaries, as well as in the EEZ, may be collected if it is needed for
proper implementation of the FMP and cannot be obtained otherwise. The
FMP should explain the practical utility of the information specified
in monitoring the fishery, in facilitating inseason management
decisions, and in judging the performance of the management regime; it
should also consider the effort, cost, or social impact of obtaining
it.
(2) An FMP should identify scientific information needed from other
sources to improve understanding and management of the resource and the
fishery.
(3) The information submitted by various data suppliers about the
stocks(s) throughout its range or about the fishery should be
comparable and compatible, to the maximum extent possible.
(d) FMP amendment. FMPs should be amended on a timely basis, as new
information indicates the necessity for change in objectives or
management measures.
(e) SAFE Report. (1) The SAFE report is a document or set of
documents that provides Councils with a summary of the most recent
biological condition of species in the FMU, and the social and economic
condition of the recreational and commercial fishing interests and the
fish processing industries. It summarizes, on a periodic basis, the
best available scientific information concerning the past, present, and
possible future condition of the stocks and fisheries being managed
under Federal regulation.
(i) The Secretary has the responsibility to assure that a SAFE
report or similar document is prepared, reviewed annually, and changed
as necessary for each FMP. The Secretary or Councils may utilize any
combination of talent from Council, state, Federal, university, or
other sources to acquire and analyze data and produce the SAFE report.
(ii) The SAFE report provides information to the Councils for
determining annual harvest levels from each stock, documenting
significant trends or changes in the resource and fishery over time,
and assessing the relative success of existing state and Federal
fishery management programs. In addition, the SAFE report may be used
to update or expand previous environmental and regulatory impact
[[Page 19403]]
documents, and ecosystem and habitat descriptions.
(iii) Each SAFE report must be scientifically based, and cite data
sources and interpretations.
(2) Each SAFE report should contain information on which to base
harvest specifications.
(3) Each SAFE report should contain information on which to assess
the social and economic condition of the persons and businesses that
rely on the use of fish resources, including fish processing
industries.
(4) Each SAFE report may contain additional economic, social, and
ecological information pertinent to the success of management or the
achievement of objectives of each FMP.
Sec. 600.320 National Standard 3--Management Units.
(a) Standard 3. To the extent practicable, an individual stock of
fish shall be managed as a unit throughout its range, and interrelated
stocks of fish shall be managed as a unit or in close coordination.
(b) General. The purpose of this standard is to induce a
comprehensive approach to fishery management. The geographic scope of
the fishery, for planning purposes, should cover the entire range of
the stocks(s) of fish, and not be overly constrained by political
boundaries. Wherever practicable, an FMP should seek to manage
interrelated stocks of fish.
(c) Unity of management. Cooperation and understanding among
entities concerned with the fishery (e.g., Councils, states, Federal
Government, international commissions, foreign nations) are vital to
effective management. Where management of a fishery involves multiple
jurisdictions, coordination among the several entities should be sought
in the development of an FMP. Where a range overlaps Council areas, one
FMP to cover the entire range is preferred. The Secretary designates
which Council(s) will prepare the FMP, under section 304(f) of the
Magnuson Act.
(d) Management unit. The term ``management unit'' means a fishery
or that portion of a fishery identified in an FMP as relevant to the
FMP's management objectives.
(1) Basis. The choice of a management unit depends on the focus of
the FMP's objectives, and may be organized around biological,
geographic, economic, technical, social, or ecological perspectives.
For example:
(i) Biological--could be based on a stock(s) throughout its range.
(ii) Geographic--could be an area.
(iii) Economic--could be based on a fishery supplying specific
product forms.
(iv) Technical--could be based on a fishery utilizing a specific
gear type or similar fishing practices.
(v) Social--could be based on fishermen as the unifying element,
such as when the fishermen pursue different species in a regular
pattern throughout the year.
(vi) Ecological--could be based on species that are associated in
the ecosystem or are dependent on a particular habitat.
(2) Conservation and management measures. FMPs should include
conservation and management measures for that part of the management
unit within U.S. waters, although the Secretary can ordinarily
implement them only within the EEZ. The measures need not be identical
for each geographic area within the management unit, if the FMP
justifies the differences. A management unit may contain, in addition
to regulated species, stocks of fish for which there is not enough
information available to specify MSY and OY or to establish management
measures, so that data on these species may be collected under the FMP.
(e) Analysis. To document that an FMP is as comprehensive as
practicable, it should include discussions of the following:
(1) The range and distribution of the stocks, as well as the
patterns of fishing effort and harvest.
(2) Alternative management units and reasons for selecting a
particular one. A less-than-comprehensive management unit may be
justified if, for example, complementary management exits or is planned
for a separate geographic area or for a distinct use of the stocks, or
if the unmanaged portion of the resource is immaterial to proper
management.
(3) Management activities and habitat programs of adjacent states
and their effects on the FMP's objectives and management measures.
Where state action is necessary to implement measures within state
waters to achieve FMP objectives, the FMP should identify what state
action is necessary, discuss the consequences of state inaction or
contrary action, and make appropriate recommendations. The FMP should
also discuss the impact that Federal regulations will have on state
management activities.
(4) Management activities of other countries having an impact on
the fishery, and how the FMP's management measures are designed to take
into account these impacts. International boundaries may be dealt with
in several ways. For example:
(i) By limiting the management unit's scope to that portion of the
stock found in U.S. waters;
(ii) By estimating MSY for the entire stock and then basing the
determination of OY for the U.S. fishery on the portion of the stock
within U.S. waters; or
(iii) By referring to treaties or cooperative agreements.
Sec. 600.325 National Standard 4--Allocations.
(a) Standard 4. Conservation and management measures shall not
discriminate between residents of different states. If it becomes
necessary to allocate or assign fishing privileges among various U.S.
fishermen, such allocation shall be:
(1) Fair and equitable to all such fishermen;
(2) Reasonably calculated to promote conservation; and
(3) Carried out in such manner that no particular individual,
corporation, or other entity acquires an excessive share of such
privileges.
(b) Discrimination among residents of different states. An FMP may
not differentiate among U.S. citizens, nationals, resident aliens, or
corporations on the basis of their state of residence. An FMP may not
incorporate or rely on a state statute or regulation that discriminates
against residents of another state. Conservation and management
measures that have different effects on persons in various geographic
locations are permissible, if they satisfy the other guidelines under
Standard 4. Examples of these precepts are:
(1) An FMP that restricted fishing in the EEZ to those holding a
permit from state X would violate Standard 4 if state X issued permits
only to its own citizens.
(2) An FMP that closed a spawning ground might disadvantage
fishermen living in the state closest to it, because they would have to
travel farther to an open area, but the closure could be justified
under Standard 4 as a conservation measure with no discriminatory
intent.
(c) Allocation of fishing privileges. An FMP may contain management
measures that allocate fishing privileges if such measures are
necessary or helpful in furthering legitimate objectives or in
achieving the OY, and if the measures conform with paragraphs (c)(3)(i)
through (c)(3)(iii) of this section.
(1) Definition. An ``allocation'' or ``assignment'' of fishing
privileges is a direct and deliberate distribution of the opportunity
to participate in a fishery among identifiable, discrete user groups
[[Page 19404]]
or individuals. Any management measure (or lack of management) has
incidental allocative effects, but only those measures that result in
direct distributions of fishing privileges will be judged against the
allocation requirements of Standard 4. Adoption of an FMP that merely
perpetuates existing fishing practices may result in an allocation, if
those practices directly distribute the opportunity to participate in
the fishery. Allocations of fishing privileges include, for example,
per-vessel catch limits, quotas by vessel class and gear type,
different quotas or fishing seasons for recreational and commercial
fishermen, assignment of ocean areas to different gear users, and
limitation of permits to a certain number of vessels or fishermen.
(2) Analysis of allocations. Each FMP should contain a description
and analysis of the allocations existing in the fishery and of those
made in the FMP. The effects of eliminating an existing allocation
system should be examined. Allocation schemes considered, but rejected
by the Council, should be included in the discussion. The analysis
should relate the recommended allocations to the FMP's objectives and
OY specification, and discuss the factors listed in paragraph (c)(3) of
this section.
(3) Factors in making allocations. An allocation of fishing
privileges must be fair and equitable, must be reasonably calculated to
promote conservation, and must avoid excessive shares. These tests are
explained in paragraphs (c)(3)(i) through (c)(3)(iii) of this section:
(i) Fairness and equity. (A) An allocation of fishing privileges
should be rationally connected to the achievement of OY or with the
furtherance of a legitimate FMP objective. Inherent in an allocation is
the advantaging of one group to the detriment of another. The motive
for making a particular allocation should be justified in terms of the
objectives of the FMP; otherwise, the disadvantaged user groups or
individuals would suffer without cause. For instance, an FMP objective
to preserve the economic status quo cannot be achieved by excluding a
group of long-time participants in the fishery. On the other hand,
there is a rational connection between an objective of harvesting
shrimp at their maximum size and closing a nursery area to trawling.
(B) An allocation of fishing privileges may impose a hardship on
one group if it is outweighed by the total benefits received by another
group or groups. An allocation need not preserve the status quo in the
fishery to qualify as ``fair and equitable,'' if a restructuring of
fishing privileges would maximize overall benefits. The Council should
make an initial estimate of the relative benefits and hardships imposed
by the allocation, and compare its consequences with those of
alternative allocation schemes, including the status quo. Where
relevant, judicial guidance and government policy concerning the rights
of treaty Indians and aboriginal Americans must be considered in
determining whether an allocation is fair and equitable.
(ii) Promotion of conservation. Numerous methods of allocating
fishing privileges are considered ``conservation and management''
measures under section 303 of the Magnuson Act. An allocation scheme
may promote conservation by encouraging a rational, more easily managed
use of the resource. Or, it may promote conservation (in the sense of
wise use) by optimizing the yield, in terms of size, value, market mix,
price, or economic or social benefit of the product.
(iii) Avoidance of excessive shares. An allocation scheme must be
designed to deter any person or other entity from acquiring an
excessive share of fishing privileges, and to avoid creating conditions
fostering inordinate control, by buyers or sellers, that would not
otherwise exist.
(iv) Other factors. In designing an allocation scheme, a Council
should consider other factors relevant to the FMP's objectives.
Examples are economic and social consequences of the scheme, food
production, consumer interest, dependence on the fishery by present
participants and coastal communities, efficiency of various types of
gear used in the fishery, transferability of effort to and impact on
other fisheries, opportunity for new participants to enter the fishery,
and enhancement of opportunities for recreational fishing.
Sec. 600.330 National Standard 5--Efficiency.
(a) Standard 5. Conservation and management measures shall, where
practicable, promote efficiency in the utilization of fishery
resources; except that no such measure shall have economic allocation
as its sole purpose.
(b) Efficiency in the utilization of resources--(1) General. The
term ``utilization'' encompasses harvesting, processing, and marketing,
since management decisions affect all three sectors of the industry.
The goal of promoting efficient utilization of fishery resources may
conflict with other legitimate social or biological objectives of
fishery management. In encouraging efficient utilization of fishery
resources, this standard highlights one way that a fishery can
contribute to the Nation's benefit with the least cost to society:
Given a set of objectives for the fishery, an FMP should contain
management measures that result in as efficient a fishery as is
practicable or desirable.
(2) Efficiency. In theory, an efficient fishery would harvest the
OY with the minimum use of economic inputs, such as labor, capital,
interest, and fuel. Efficiency in terms of aggregate costs then becomes
a conservation objective, where ``conservation'' constitutes wise use
of all resources involved in the fishery, not just fish stocks.
(i) In an FMP, management measures may be proposed that allocate
fish among different groups of individuals or establish a system of
property rights. Alternative measures examined in searching for an
efficient outcome will result in different distributions of gains and
burdens among identifiable user groups. An FMP should demonstrate that
management measures aimed at efficiency do not simply redistribute
gains and burdens without an increase in efficiency.
(ii) Management regimes that allow a fishery to operate at the
lowest possible cost (e.g., fishing effort, administration, and
enforcement) for a particular level of catch and initial stock size are
considered efficient. Restrictive measures that unnecessarily raise any
of those costs move the regime toward inefficiency. Unless the use of
inefficient techniques or the creation of redundant fishing capacity
contributes to the attainment of other social or biological objectives,
an FMP may not contain management measures that impede the use of cost-
effective techniques of harvesting, processing, or marketing, and
should avoid creating strong incentives for excessive investment in
private sector fishing capital and labor.
(c) Limited access. A ``system for limiting access,'' which is an
optional measure under section 303(b) of the Magnuson Act, is a type of
allocation of fishing privileges that may be used to promote economic
efficiency or conservation. For example, limited access may be used to
combat overfishing, overcrowding, or overcapitalization in a fishery to
achieve OY. In an unutilized or underutilized fishery, it may be used
to reduce the chance that these conditions will adversely affect the
fishery in the future, or to provide adequate economic return to
pioneers in a new fishery. In some cases, limited entry is a useful
ingredient of a conservation scheme, because it facilitates application
and enforcement of other management measures.
[[Page 19405]]
(1) Definition. Limited access (or limited entry) is a management
technique that attempts to limit units of effort in a fishery, usually
for the purpose of reducing economic waste, improving net economic
return to the fishermen, or capturing economic rent for the benefit of
the taxpayer or the consumer. Common forms of limited access are
licensing of vessels, gear, or fishermen to reduce the number of units
of effort, and dividing the total allowable catch into fishermen's
quotas (a stock-certificate system). Two forms (i.e., Federal fees for
licenses or permits in excess of administrative costs, and taxation)
are not permitted under the Magnuson Act.
(2) Factors to consider. The Magnuson Act ties the use of limited
access to the achievement of OY. An FMP that proposes a limited access
system must consider the factors listed in section 303(b)(6) of the
Magnuson Act and in Sec. 600.325(c)(3). In addition, it should consider
the criteria for qualifying for a permit, the nature of the interest
created, whether to make the permit transferable, and the Magnuson
Act's limitation on returning economic rent to the public under section
304(d)(1). The FMP should also discuss the costs of achieving an
appropriate distribution of fishing privileges.
(d) Analysis. An FMP should discuss the extent to which
overcapitalization, congestion, economic waste, and inefficient
techniques in the fishery reduce the net benefits derived from the
management unit and prevent the attainment and appropriate allocation
of OY. It should also explain, in terms of the FMP's objectives, any
restriction placed on the use of efficient techniques of harvesting,
processing, or marketing. If, during FMP development, the Council
considered imposing a limited-entry system, the FMP should analyze the
Council's decision to recommend or reject limited access as a technique
to achieve efficient utilization of the resources of the fishing
industry.
(e) Economic allocation. This standard prohibits only those
measures that distribute fishery resources among fishermen on the basis
of economic factors alone, and that have economic allocation as their
only purpose. Where conservation and management measures are
recommended that would change the economic structure of the industry or
the economic conditions under which the industry operates, the need for
such measures must be justified in light of the biological, ecological,
and social objectives of the FMP, as well as the economic objectives.
Sec. 600.335 National Standard 6--Variations and Contingencies.
(a) Standard 6. Conservation and management measures shall take
into account and allow for variations among, and contingencies in,
fisheries, fishery resources, and catches.
(b) Conservation and management. Each fishery exhibits unique
uncertainties. The phrase ``conservation and management'' implies the
wise use of fishery resources through a management regime that includes
some protection against these uncertainties. The particular regime
chosen must be flexible enough to allow timely response to resource,
industry, and other national and regional needs. Continual data
acquisition and analysis will help the development of management
measures to compensate for variations and to reduce the need for
substantial buffers. Flexibility in the management regime and the
regulatory process will aid in responding to contingencies.
(c) Variations. (1) In fishery management terms, variations arise
from biological, social, and economic occurrences, as well as from
fishing practices. Biological uncertainties and lack of knowledge can
hamper attempts to estimate stock size and strength, stock location in
time and space, environmental/habitat changes, and ecological
interactions. Economic uncertainty may involve changes in foreign or
domestic market conditions, changes in operating costs, drifts toward
overcapitalization, and economic perturbations caused by changed
fishing patterns. Changes in fishing practices, such as the
introduction of new gear, rapid increases or decreases in harvest
effort, new fishing strategies, and the effects of new management
techniques, may also create uncertainties. Social changes could involve
increases or decreases in recreational fishing, or the movement of
people into or out of fishing activities due to such factors as age or
educational opportunities.
(2) Every effort should be made to develop FMPs that discuss and
take into account these vicissitudes. To the extent practicable, FMPs
should provide a suitable buffer in favor of conservation. Allowances
for uncertainties should be factored into the various elements of an
FMP. Examples are:
(i) Reduce OY. Lack of scientific knowledge about the condition of
a stock(s) could be reason to reduce OY.
(ii) Establish a reserve. Creation of a reserve may compensate for
uncertainties in estimating domestic harvest, stock conditions, or
environmental factors.
(iii) Adjust management techniques. In the absence of adequate data
to predict the effect of a new regime, and to avoid creating unwanted
variations, a Council could guard against producing drastic changes in
fishing patterns, allocations, or practices.
(iv) Highlight habitat conditions. FMPs may address the impact of
pollution and the effects of wetland and estuarine degradation on the
stocks of fish; identify causes of pollution and habitat degradation
and the authorities having jurisdiction to regulate or influence such
activities; propose recommendations that the Secretary will convey to
those authorities to alleviate such problems; and state the views of
the Council on unresolved or anticipated issues.
(d) Contingencies. Unpredictable events--such as unexpected
resource surges or failures, fishing effort greater than anticipated,
disruptive gear conflicts, climatic conditions, or environmental
catastrophes--are best handled by establishing a flexible management
regime that contains a range of management options through which it is
possible to act quickly without amending the FMP or even its
regulations.
(1) The FMP should describe the management options and their
consequences in the necessary detail to guide the Secretary in
responding to changed circumstances, so that the Council preserves its
role as policy-setter for the fishery. The description should enable
the public to understand what may happen under the flexible regime, and
to comment on the options.
(2) FMPs should include criteria for the selection of management
measures, directions for their application, and mechanisms for timely
adjustment of management measures comprising the regime. For example,
an FMP could include criteria that allow the Secretary to open and
close seasons, close fishing grounds, or make other adjustments in
management measures.
(3) Amendment of a flexible FMP would be necessary when
circumstances in the fishery change substantially, or when a Council
adopts a different management philosophy and objectives.
Sec. 600.340 National Standard 7--Costs and Benefits.
(a) Standard 7. Conservation and management measures shall, where
practicable, minimize costs and avoid unnecessary duplication.
(b) Necessity of Federal management--(1) General. The principle
that not every fishery needs regulation is implicit in this standard.
The Magnuson Act does not require Councils to prepare FMPs for each and
every fishery--only for those where
[[Page 19406]]
regulation would serve some useful purpose and where the present or
future benefits of regulation would justify the costs. For example, the
need to collect data about a fishery is not, by itself, adequate
justification for preparation of an FMP, since there are less costly
ways to gather the data (see Sec. 600.320(d)(2)). In some cases, the
FMP preparation process itself, even if it does not culminate in a
document approved by the Secretary, can be useful in supplying a basis
for management by one or more coastal states.
(2) Criteria. In deciding whether a fishery needs management
through regulations implementing an FMP, the following general factors
should be considered, among others:
(i) The importance of the fishery to the Nation and to the regional
economy.
(ii) The condition of the stock or stocks of fish and whether an
FMP can improve or maintain that condition.
(iii) The extent to which the fishery could be or is already
adequately managed by states, by state/Federal programs, by Federal
regulations pursuant to FMPs or international commissions, or by
industry self-regulation, consistent with the policies and standards of
the Magnuson Act.
(iv) The need to resolve competing interests and conflicts among
user groups and whether an FMP can further that resolution.
(v) The economic condition of a fishery and whether an FMP can
produce more efficient utilization.
(vi) The needs of a developing fishery, and whether an FMP can
foster orderly growth.
(vii) The costs associated with an FMP, balanced against the
benefits (see paragraph (d) of this section as a guide).
(c) Alternative management measures. Management measures should not
impose unnecessary burdens on the economy, on individuals, on private
or public organizations, or on Federal, state, or local governments.
Factors such as fuel costs, enforcement costs, or the burdens of
collecting data may well suggest a preferred alternative.
(d) Analysis. The supporting analyses for FMPs should demonstrate
that the benefits of fishery regulation are real and substantial
relative to the added research, administrative, and enforcement costs,
as well as costs to the industry of compliance. In determining the
benefits and costs of management measures, each management strategy
considered and its impacts on different user groups in the fishery
should be evaluated. This requirement need not produce an elaborate,
formalistic cost/benefit analysis. Rather, an evaluation of effects and
costs, especially of differences among workable alternatives, including
the status quo, is adequate. If quantitative estimates are not
possible, qualitative estimates will suffice.
(1) Burdens. Management measures should be designed to give
fishermen the greatest possible freedom of action in conducting
business and pursuing recreational opportunities that are consistent
with ensuring wise use of the resources and reducing conflict in the
fishery. The type and level of burden placed on user groups by the
regulations need to be identified. Such an examination should include,
for example: Capital outlays; operating and maintenance costs;
reporting costs; administrative, enforcement, and information costs;
and prices to consumers. Management measures may shift costs from one
level of government to another, from one part of the private sector to
another, or from the government to the private sector. Redistribution
of costs through regulations is likely to generate controversy. A
discussion of these and any other burdens placed on the public through
FMP regulations should be a part of the FMP's supporting analyses.
(2) Gains. The relative distribution of gains may change as a
result of instituting different sets of alternatives, as may the
specific type of gain. The analysis of benefits should focus on the
specific gains produced by each alternative set of management measures,
including the status quo. The benefits to society that result from the
alternative management measures should be identified, and the level of
gain assessed.
Subpart E--Confidentiality of Statistics
Sec. 600.405 Types of statistics covered.
NOAA is authorized under the Magnuson Act and other statutes to
collect proprietary or confidential commercial or financial
information. This part applies to all pertinent data required to be
submitted to the Secretary with respect to any FMP including, but not
limited to, information regarding the type and quantity of fishing gear
used, catch by species in numbers of fish or weight thereof, areas in
which fishing occurred, time of fishing, number of hauls, and the
estimated processing capacity of, and the actual processing capacity
utilized by, U.S. fish processors.
Sec. 600.410 Collection and maintenance of statistics.
(a) General. (1) All statistics required to be submitted to the
Secretary are provided to the Assistant Administrator.
(2) After receipt, the Assistant Administrator will remove all
identifying particulars from the statistics if doing so is consistent
with the needs of NMFS and good scientific practice.
(3) Appropriate safeguards as specified by NOAA Directives, or
other NOAA or NMFS internal procedures, apply to the collection and
maintenance of all statistics, whether separated from identifying
particulars or not, so as to ensure their confidentiality.
(b) Collection agreements with states. (1) The Assistant
Administrator may enter into an agreement with a state authorizing the
state to collect statistics on behalf of the Secretary.
(2) NMFS will not enter into a cooperative collection agreement
with a state unless the state has authority to protect the statistics
from disclosure in a manner at least as protective as these
regulations.
Sec. 600.415 Access to statistics.
(a) General. In determining whether to grant a request for access
to confidential data, the following information will be taken into
consideration:
(1) The specific types of data required;
(2) The relevance of the data to conservation and management
issues;
(3) The duration of time access will be required: continuous,
infrequent, or one-time; and
(4) An explanation of why the availability of aggregate or non-
confidential summaries of data from other sources would not satisfy the
requested needs.
(b) Federal employees. Statistics submitted as a requirement of an
FMP and that reveal the identity of the submitter will only be
accessible to the following:
(1) Personnel within NMFS responsible for the collection,
processing, and storage of the statistics;
(2) Federal employees who are responsible for FMP development,
monitoring, and enforcement;
(3) Personnel within NMFS performing research that requires
confidential statistics;
(4) Other NOAA personnel on a demonstrable need-to-know basis; and
(5) NOAA/NMFS contractors or grantees who require access to
confidential statistics to perform functions authorized by a Federal
contract or grant.
(c) State personnel. Upon written request, confidential statistics
will only be accessible if:
(1) State employees demonstrate a need for confidential statistics
for use in fishery conservation and management; and
[[Page 19407]]
(2) The state has entered into a written agreement between the
Assistant Administrator and the head of the state's agency that manages
marine and/or anadromous fisheries. The agreement shall contain a
finding by the Assistant Administrator that the state has
confidentiality protection authority comparable to the Magnuson Act,
and that the state will exercise this authority to limit subsequent
access and use of the data to fishery management and monitoring
purposes.
(d) Councils. Upon written request by the Council Executive
Director, access to confidential data will be granted to:
(1) Council employees who are responsible for FMP development and
monitoring.
(2) A Council for use by the Council for conservation and
management purposes, with the approval of the Assistant Administrator.
In addition to the information described in paragraph (a) of this
section, the Assistant Administrator will consider the following in
deciding whether to grant access:
(i) The possibility that Council members might gain personal or
competitive advantage from access to the data; and
(ii) The possibility that the suppliers of the data would be placed
at a competitive disadvantage by public disclosure of the data at
Council meetings or hearings.
(3) A contractor of the Council for use in such analysis or studies
necessary for conservation and management purposes, with approval of
the Assistant Administrator and execution of an agreement with NMFS as
described by NOAA Administrative Order (NAO) 216-100.
(e) Prohibitions. Persons having access to these data are
prohibited from unauthorized use or disclosure, and are subject to the
provisions of 18 U.S.C. 1905, 16 U.S.C. 1857, and NOAA/NMFS internal
procedures, including NAO 216-100.
Sec. 600.420 Control system.
(a) The Assistant Administrator maintains a control system to
protect the identity of submitters of statistics required by an FMP.
The control system:
(1) Identifies those persons who have access to the statistics;
(2) Contains procedures to limit access to confidential data to
authorized users; and
(3) Provides for safeguarding the data.
(b) This system requires that all persons who have authorized
access to the data be informed of the confidentiality of the data.
These persons are required to sign a statement that they:
(1) Have been informed that the data are confidential; and
(2) Have reviewed and are familiar with the procedures to protect
confidential statistics.
Sec. 600.425 Release of statistics.
(a) The Assistant Administrator will not release to the public any
statistics required to be submitted under an FMP in a form that would
identify the submitter, except as required by law.
(b) All requests from the public for statistics submitted in
response to a requirement of an FMP will be processed consistent with
the NOAA FOIA regulations (15 CFR part 903), NAO 205-14, Department of
Commerce Administrative Orders 205-12 and 205-14 and 15 CFR part 4.
(c) NOAA does not release or allow access to confidential
information in its possession to members of Council advisory groups,
except as provided by law.
Subpart F--Foreign Fishing
Sec. 600.501 Vessel permits.
(a) General. (1) Each FFV fishing under the Magnuson Act must have
on board a permit issued under this section, unless it is engaged only
in recreational fishing.
(2) Permits issued under this section do not authorize FFV's or
persons to harass, capture, or kill marine mammals. No marine mammals
may be taken in the course of fishing unless that vessel has on board a
currently valid Authorization Certificate under the MMPA. Regulations
governing the taking of marine mammals incidental to commercial fishing
operations are contained in 50 CFR part 229 of this title.
(b) Responsibility of owners and operators. The owners and
operators of each FFV are jointly and severally responsible for
compliance with the Magnuson Act, the applicable GIFA, this subpart,
and any permit issued under the Magnuson Act and this subpart. The
owners and operators of each FFV bear civil responsibility for the acts
of their employees and agents constituting violations, regardless of
whether the specific acts were authorized or even forbidden by the
employer or principal, and regardless of knowledge concerning the
occurrence.
(c) Activity codes. Permits to fish under a GIFA may be issued by
the Assistant Administrator for the activities described in this
paragraph, but the permits may be modified by regulations of this
subpart, and by the conditions and restrictions attached to the permit
(see paragraphs (e)(1) and (e)(1)(v) of this section). The Assistant
Administrator may issue a permit, as appropriate, for one or more of
the activity codes listed below. The activity codes are described as
follows:
(1) Activity Code 1. Catching, scouting, processing, transshipping,
and supporting foreign vessels. Activity is limited to fish harvested
or to be harvested by foreign vessels in the EEZ.
(2) Activity Code 2. Processing, scouting, transshipping, and
supporting foreign vessels. Activity is limited to fish harvested or to
be harvested by foreign vessels in the EEZ.
(3) Activity Code 3. Transshipping, scouting, and supporting
foreign vessels. Activity is limited to fish harvested or to be
harvested by foreign vessels in the EEZ.
(4) Activity Code 4. Processing, scouting, transshipping, and
supporting U.S. vessels delivering fish to foreign vessels. Activity is
limited to the receipt of unprocessed fish harvested or to be harvested
by U.S. vessels.
(5) Activity Code 5. Transshipping, scouting, and supporting
foreign vessels. Transshipment limited to fish received or to be
received from foreign vessels processing fish from U.S. harvesting
vessels.
(6) Activity Code 6. Transshipping, scouting, and supporting U.S.
vessels. Transshipment limited to U.S.-harvested fish processed on
board U.S. vessels.
(7) Activity Code 7. Processing, transshipping, and supporting
foreign vessels. Activity limited to fish harvested or to be harvested
by foreign vessels seaward of the EEZ.
(8) Activity Code 8. Transshipping and supporting foreign vessels.
Activity is limited to fish harvested or to be harvested seaward of the
EEZ by foreign vessels or fish duly authorized for processing in the
internal waters of one of the states.
(9) Activity Code 9. Supporting U.S. fishing vessels and U.S. fish
processing vessels and any foreign fishing vessels authorized under any
activity code under paragraph (c) of this subpart.
(d) Application. (1) Applications for FFV permits must be submitted
by each foreign nation to the DOS. Application forms are available from
OES/OMC, DOS, Washington, DC. The applicant should allow 90 days for
review and comment by the public, involved governmental agencies, and
appropriate Councils, and for processing before the anticipated date to
begin fishing. The permit application fee must be paid at the time of
application according to Sec. 600.518.
[[Page 19408]]
(2) Applicants must provide complete and accurate information
requested on the permit application form.
(3) Applicants for FFV's that will support U.S. vessels in joint
ventures (Activity Code 4) must provide the additional information
specified by the permit application form.
(4) Each foreign nation may substitute one FFV for another by
submitting a new vessel information form and a short explanation of the
reason for the substitution to the DOS. Each substitution is considered
a new application and a new application fee must be paid. NMFS will
promptly process an application for a vessel replacing a permitted FFV
that is disabled or decommissioned, once the DOS has notified the
appropriate Council(s) of the substituted application.
(e) Issuance. (1) Permits may be issued to an FFV by the Assistant
Administrator through the DOS after--
(i) The Assistant Administrator determines that the fishing
described in the application will meet the requirements of the Magnuson
Act and approves the permit application;
(ii) The foreign nation has paid the fees, including any surcharge
fees and provided any assurances required by the Secretary in
accordance with the provisions of Sec. 600.518;
(iii) The foreign nation has appointed an agent;
(iv) The foreign nation has identified a designated representative;
and
(v) The general ``conditions and restrictions'' of receiving
permits, as required by section 204(b)(7) of the Magnuson Act, and any
``additional restrictions'' attached to the permit for the conservation
and management of fishery resources or to prevent significant
impairment of the national defense or security interests, have been
accepted by the nation issuing the FFV's documents.
(2) NMFS will distribute blank permit forms to the designated
representative while the application is being processed. The designated
representative must ensure that each FFV receives a permit form and
must accurately transmit the permit form and the contents of the permit
to the FFV when it is issued. NMFS may authorize the modification and
use of the previous year's permit forms to be used on an interim basis
in place of the current year's permit forms if the current forms were
not made available to the designated representatives for timely
distribution. The FFV owner or operator must accurately complete the
permit form prior to fishing in the EEZ.
(3) A completed permit form must contain--
(i) The name and IRCS of the FFV and its permit number;
(ii) The permitted fisheries and activity codes;
(iii) The date of issuance and expiration date, if other than
December 31; and
(iv) All conditions and restrictions, and any additional
restrictions and technical modifications appended to the permit.
(4) Permits are not issued for boats that are launched from larger
vessels. Any enforcement action that results from the activities of a
launched boat will be taken against the permitted vessel.
(f) Duration. A permit is valid from its date of issuance to its
date of expiration, unless it is revoked or suspended or the nation
issuing the FFV's documents does not accept amendments to the permit
made by the Assistant Administrator in accordance with the procedures
of paragraph (l) of this section. The permit will be valid for no
longer than the calendar year in which it was issued.
(g) Transfer. Permits are not transferable or assignable. A permit
is valid only for the FFV to which it is issued.
(h) Display. Each FFV operator must have a properly completed
permit form available on board the FFV when engaged in fishing
activities and must produce it at the request of an authorized officer
or observer.
(i) Suspension and revocation. NMFS may apply sanctions to an FFV's
permit by revoking, suspending, or imposing additional permit
restrictions on the permit under 15 CFR part 904, if the vessel is
involved in the commission of any violation of the Magnuson Act, the
GIFA, or this subpart; if an agent and a designated representative are
not maintained in the United States; if a civil penalty or criminal
fine imposed under the Magnuson Act has become overdue; or as otherwise
specified in the Magnuson Act.
(j) Fees. Permit application fees are described in Sec. 600.518.
(k) Change in application information. (1) The foreign nation must
report, in writing, any change in the information supplied under
paragraph (d) of this section to the Assistant Administrator within 15
calendar days after the date of the change. Failure to report a change
in the ownership from that described in the current application within
the specified time frame voids the permit, and all penalties involved
will accrue to the previous owner.
(2) The Assistant Administrator may make technical modifications or
changes in the permit application requested or reported by a Nation,
such as a change in radio call sign, processing equipment, or tonnage,
which will be effective immediately.
(3) If, in the opinion of the Assistant Administrator, a permit
change requested by a Nation could significantly affect the status of
any fishery resource, such request will be processed as an application
for a new permit under this section.
(4) The Assistant Administrator will notify the designated
representative of any revision that must be made on the permit form as
the result of a permit change.
(5) The vessel owner or operator must record the modification on
the permit form.
(l) Permit amendments. (1) The Assistant Administrator may amend a
permit by adding ``additional restrictions'' for the conservation and
management of fishery resources covered by the permit, or for the
national defense or security if the Assistant Administrator determines
that such interests would be significantly impaired without such
restrictions. Compliance with the added additional restrictions is a
condition of the permit. Violations of added additional restrictions
will be treated as violations of this subpart.
(2) The Assistant Administrator may make proposed additional
restrictions effective immediately, if necessary, to prevent
substantial harm to a fishery resource of the United States, to allow
for the continuation of ongoing fishing operations, or to allow for
fishing to begin at the normal time for opening of the fishery.
(3) The Assistant Administrator will send proposed additional
restrictions to each Nation whose vessels are affected (via the
Secretary of State), to the appropriate Councils, and to the Commandant
of the Coast Guard. NMFS will, at the same time, publish a document of
any significant proposed additional restrictions in the Federal
Register. The document will include a summary of the reasons underlying
the proposal, and the reasons that any proposed additional restrictions
are made effective immediately.
(4) The Nation whose vessels are involved, the owners of the
affected vessels, their representatives, the agencies specified in
paragraph (l)(3) of this section, and the public may submit written
comments on the proposed additional restrictions within 30 days after
publication in the Federal Register.
[[Page 19409]]
(5) The Assistant Administrator will make a final decision
regarding the proposed additional restrictions as soon as practicable
after the end of the comment period. The Assistant Administrator will
provide the final additional restrictions to the Nation whose vessels
are affected (via the Secretary of State) according to the procedures
of paragraph (e) of this section. The Assistant Administrator will
include with the final additional restrictions to the Nation, a
response to comments submitted.
(6) Additional restrictions may be modified by following the
procedures of paragraphs (l)(2) through (l)(5) of this section.
Sec. 600.502 Vessel reports.
(a) The operator of each FFV must report the FFV's activities
within the EEZ to the USCG and NMFS as specified in this section.
(b) All reports required by this section must be in English and in
the formats specified in the permit additions and restrictions. Reports
must be delivered via private or commercial communications facilities,
facsimile, or other electronic means acceptable to NMFS and the USCG,
directly to the appropriate NMFS Region or Center and USCG commander.
Weekly reports must also be delivered directly to the appropriate NMFS
Region or Center (see tables 1 and 2 of this section). (The required
reports may be delivered to the closest USCG communication station as
indicated in table 3 of this section or other USCG communication
station only if adequate private or commercial communications
facilities have not been successfully contacted.) Radio reports must be
made via radiotelegraphy, Telex, or facsimile where available. For the
purposes of this section, a message is considered ``transmitted'' when
its receipt is acknowledged by a communications facility and considered
``delivered'' upon its receipt by the offices of the appropriate USCG
commander, NMFS Regional Office, or NMFS Center identified in table 3
of this section. Reports required by this section may be submitted by
the vessel's designated representative; however, the operator of the
FFV is responsible for the correct and timely filing of all required
reports.
(c) Activity reports. The operator of each FFV must report the
FFV's movements and activities before or upon the event, as specified
in this paragraph (c). Appropriate forms, instructions, codes, and
examples are contained in the conditions and restrictions of the FFV's
permit. Each FFV report must contain the following information: The
message identifier ``VESREP'' to indicate it is a vessel activity
report, FFV name, international radio call sign IRCS, date (month and
day based on GMT), time (hour and minute GMT), position (latitude and
longitude to the nearest degree and minute) where required, area (by
fishing area code) where required, the appropriate action code,
confirmation codes where required, and the other information specified
in paragraphs (c)(1) through (c)(11) of this section.
(1)``BEGIN''. Each operator must specify the date, time, position
and area the FFV will actually ``BEGIN'' fishing in the EEZ and the
species (by species code), product (by product code), and quantity of
all fish and fish products (by product weight to the nearest hundredth
of a metric ton) on board when entering the EEZ (action code
``BEGIN''). The message must be delivered at least 24 hours before the
vessel begins to fish.
(2) ``DEPART''. Each operator must specify the date, time,
position, and area the FFV will ``DEPART'' the EEZ to embark or debark
an observer, to visit a U.S. port, to conduct a joint venture in
internal waters, or to otherwise temporarily leave an authorized
fishing area, but not depart the seaward limit of the EEZ (action code
``DEPART''). The message must be transmitted before the FFV departs the
present fishing area and delivered within 24 hours of its transmittal.
(3) ``RETURN''. Each operator must specify the date, time,
position, and area the FFV will ``RETURN'' to the EEZ following a
temporary departure, and the species (by species code), product (by
product code), and quantity of all fish and fish products (by product
weight to the nearest hundredth of a metric ton) on board that were
received in a joint venture in internal waters (action code
``RETURN''). The message must be transmitted before returning to the
EEZ and delivered within 24 hours of its transmittal.
(4) ``SHIFT''. Each operator must report each SHIFT in fishing area
(as described for each fishery) by specifying the date, time, and
position the FFV will start fishing, and the new area (action code
``SHIFT''). The message must be transmitted before leaving the original
area and delivered within 24 hours of its transmittal. If a foreign
vessel operates within 20 nautical miles (37.04 km) of a fishing area
boundary, its operator may submit in one message the shift reports for
all fishing area shifts occurring during 1 fishing day (0001-2400 GMT).
This message must be transmitted prior to the last shift expected to be
made in the day and delivered within 24 hours of its transmittal.
(5) ``JV OPS''. Each operator must specify the date, time,
position, and area at which the FFV will ``START'' joint venture
operations (action code ``START JV OPS'') or ``END'' joint venture
operations (action code ``END JV OPS''). These reports must be made in
addition to other activity reports made under this section. Each
message must be transmitted before the event and delivered within 24
hours of its transmittal.
(6) ``TRANSFER''. The operator of each FFV that anticipates a
transshipping operation in which the FFV will receive fish or fisheries
products must specify the date, time, position and area the FFV will
conduct the ``TRANSFER'' and the name and IRCS of the other FFV or U.S.
vessel involved (action code ``TRANSFER''). The report must include the
permit activity code under which the transfer will be made. The message
must be transmitted prior to the transfer and delivered within 24 hours
of its transmittal. The movement of raw fish from a permitted foreign
catching vessel or, under an Activity Code 4, from a U.S. fishing
vessel to the reporting processing vessel and the return of nets or
codends is not considered a transfer.
(7) ``OFFLOADED''. Each operator must specify the date, time,
position and area the FFV ``OFFLOADED'' fish or fisheries products TO
another FFV or a U.S. vessel in a transfer, the other FFV's or U.S.
vessel's name, IRCS, Permit Activity Code under which the transfer was
made, species (by species code) and quantity of fish and fisheries
products (by product code and by product weight, to the nearest
hundredth of a metric ton) offloaded (action code ``OFFLOADED TO'').
The message must be transmitted within 12 hours after the transfer is
completed and delivered within 24 hours of its transmittal and before
the FFV ceases fishing in the EEZ.
(8) ``RECEIVED''. Each operator must specify the date, time,
position and area the vessel ``RECEIVED'' fish or fisheries products
FROM another FFV in a transfer, the other FFV's or U.S. vessel's name,
IRCS, Permit Activity Code under which the receipt was made, species
(by species code) and quantity of fish and fisheries products (by
product code and by product weight, to the nearest hundredth of a
metric ton) received (action code ``RECEIVED FROM''). The message must
be transmitted within 12 hours after the transfer is completed and
delivered within 24 hours of its transmittal and before the vessel
ceases fishing in the EEZ.
[[Page 19410]]
(9) ``CEASE''. Each operator must specify the date, time, position,
and area the FFV will ``CEASE'' fishing in order to leave the EEZ
(action code ``CEASE''). The message must be delivered at least 24
hours before the FFV's departure.
(10) ``CHANGE''. Each operator must report any ``CHANGE'' TO the
FFV's operations if the position or time of an event specified in an
activity report will vary more than 5 nautical miles (9.26 km) or 4
hours from that previously reported, by sending a revised message
inserting the word ``CHANGE'' in front of the previous report,
repeating the name, IRCS, date, and time of the previous report, adding
the word ``TO'' and the complete revised text of the new report (action
code ``CHANGE TO''). Changes to reports specifying an early beginning
of fishing by an FFV or other changes to reports contained in
paragraphs (c)(1) through (c)(9) of this section must be transmitted
and delivered as if the CHANGE report were the original message.
(11) ``CANCEL''. Each operator wanting to CANCEL a previous report
may do so by sending a revised message, and inserting the word
``CANCEL'' in front of the previous report's vessel name, IRCS, date,
time and action code canceled (action code ``CANCEL''). The message
must be transmitted and delivered prior to the date and time of the
event in the original message.
(d) The operator of an FFV will be in violation of paragraphs
(c)(1) through (c)(9) of this section if the FFV does not pass within 5
nautical miles (9.26 km) of the position given in the report within 4
hours of the time given in the report.
(e) The notices required by this section may be provided for
individual or groups of FFV's (on a vessel-by-vessel basis) by
authorized persons. An FFV operator may retransmit reports on the
behalf of another FFV, if authorized by that FFV's operator. This does
not relieve the individual vessel operator of the responsibility of
filing required reports. In these cases, the message format should be
modified so that each line of text under ``VESREP'' is a separate
vessel report.
(f) Weekly reports. (1) The operator of each FFV in the EEZ must
submit appropriate weekly reports through the Nation's designated
representative. The report must arrive at the address and time
specified in paragraph (g) of this section. The reports may be sent by
facsimile or Telex, but a completed copy of the report form must be
mailed or hand delivered to confirm the Telex. Appropriate forms,
instructions, codes, and examples are contained in the conditions and
restrictions of the FFV's permit. Designated representatives may
include more than one vessel report in a facsimile or Telex message, if
the information is submitted on a vessel-by-vessel basis. Requests for
corrections to previous reports must be submitted through the Nation's
designated representative and mailed or hand-delivered, togeth
FR Doc. 96-9988 Magnuson Act Provisions; Consolidation and Update of Regulations
er with a
written explanation of the reasons for the errors. The appropriate
Regional or Science and Research Director may accept or reject any
correction and initiate any appropriate civil penalty actions.
(2) Weekly catch report (CATREP). The operator of each FFV must
submit a weekly catch report stating any catch (Activity Code 1) in
round weight of each species or species group allocated to that Nation
by area and days fished in each area for the weekly period Sunday
through Saturday, GMT, as modified by the fishery in which the FFV is
engaged. Foreign vessels delivering unsorted, unprocessed fish to a
processing vessel are not required to submit CATREP's, if that
processing vessel (Activity Code 2) submits consolidated CATREP's for
all fish received during each weekly period. No report is required for
FFV's that do not catch or receive foreign-caught fish during the
reporting period.
(3) Weekly receipts report (RECREP). The operator of each FFV must
submit a weekly report stating any receipts of U.S.-harvested fish in a
joint venture (Activity Code 4) for the weekly period Sunday through
Saturday, GMT, as modified by the fishery in which the FFV is engaged,
for each fishing area, by authorized or prohibited species or species
group; days fish received; round weight retained or returned to the
U.S. fishing vessel; number of codends received; and number of vessels
transferring codends. The report must also include the names of U.S.
fishing vessels transferring codends during the week. No report is
required for FFV's that do not receive any U.S.-harvested fish during
the reporting period.
(4) Marine mammal report (MAMREP). The operator of each FFV must
submit a weekly report stating any incidental catch or receipt of
marine mammals (Activity Codes 1 or 2 and/or 4), the geographical
position caught, the condition of the animal, number caught (if more
than one of the same species and condition), and nationality of the
catching vessel for the period Sunday through Saturday, GMT, as
modified by the fishery in which the vessel is engaged. Foreign
catching vessels delivering unsorted, unprocessed fish to processing
vessel are not required to submit MAMREP's, provided that the
processing or factory vessel (Activity Code 2) submits consolidated
MAMREP's for all fish received during each weekly period. FFV's
receiving U.S.-harvested fish in a joint venture (Activity Code 4) must
submit consolidated reports for U.S. vessels operating in the joint
venture. No report is required for FFV's that do not catch or receive
marine mammals during the reporting period.
(g) Submission instructions for weekly reports. The designated
representative for each FFV must submit weekly reports in the
prescribed format to the appropriate Regional or Science and Research
Director of NMFS by 1900 GMT on the Wednesday following the end of the
reporting period. However, by agreement with the appropriate Director,
the designated representative may submit weekly reports to some other
facility of NMFS.
Table 1to Sec. 600.502--Addresses
----------------------------------------------------------------------------------------------------------------
NMFS regional directors NMFS science and research directors U.S. Coast Guard commanders
----------------------------------------------------------------------------------------------------------------
Director, Northeast Region, National Director, Northeast Fisheries Science Commander, Atlantic Area,
Marine Fisheries Service, NOAA, One Center, National Marine Fisheries U.S. Coast Guard, Governor's
Blackburn Drive, Gloucester, MA 01930- Service, NOAA, 166 Water Street, Woods Island, New York, NY 10004.
2298. Hole, MA 02543-1097.
Director, Southeast Region, National Director, Southeast Fisheries Science Commander, Atlantic Area,
Marine Fisheries Service, NOAA, 9721 Center, National Marine Fisheries U.S. Coast Guard, Governor's
Exec. Center Drive N., St. Petersburg, Service, NOAA, 75 Virginia Beach Island, New York, NY 10004.
FL 33702. Drive, Miami, FL 33149-1003.
Director, Northwest Region, National Director, Northwest Fisheries Science Commander, Pacific Area, U.S.
Marine Fisheries Service, NOAA, 7600 Center, National Marine Fisheries Coast Guard, Government
Sand Point Way, NE, BIN C15700, Bldg. Service, NOAA, 2725 Montlake Boulevard Island, Alameda, CA 94501
1, Seattle, WA 98115. East, Seattle, WA 98112-2097.
[[Page 19411]]
Director, Alaska Region, National Marine Director, Alaska Fisheries Science Commander, Seventeenth Coast
Fisheries Service, NOAA, P.O. Box 1668, Center, National Marine Fisheries Guard District, P.O. Box
Juneau, AK 99802-1668. Service, NOAA, 7600 Sand Point Way, 25517, Juneau, AK 99802.
NE, BIN C15700, Bldg. 4, Seattle, WA
98115-0070.
Director, Southwest Region National Director, Southwest Fisheries Science Commander, Fourteenth Coast
Marine Fisheries Service, NOAA, 501 Center, National Marine Fisheries Guard District, 300 Ala
West Ocean Blvd, Suite 4200, Long Service, NOAA, P.O. Box 271, La Jolla, Moana Blvd., Honolulu, HI
Beach, CA 90802-4213. CA 92038-0271. 96850.
----------------------------------------------------------------------------------------------------------------
Table 2 to Sec. 600.502--Areas of Responsibility of NMFS and U.S. Coast Guard Offices
----------------------------------------------------------------------------------------------------------------
National Marine
Area of responsibility Fishery Fisheries Service U.S. Coast Guard
----------------------------------------------------------------------------------------------------------------
Atlantic Ocean--North of Cape Northwest Atlantic Ocean Director, Northeast Commander, Atlantic
Hatteras. Fishery, including the Center, Attn: Observer Area.
Hake Fishery. Program.
Atlantic Ocean--South of Cape Atlantic Billfish and Director, Northeast Commander, Atlantic
Hatteras. Sharks Fishery. Center, Attn: Observer Area.
Program.
Gulf of Mexico................... Royal Red Shrimp Fishery
Caribbean Sea--Pacific Ocean off Pacific Coast Groundfish Director, Northwest Commander, Pacific Area.
the States of California, Fishery. Region; Director,
Oregon, and Washington. Northwest Fisheries
Science Center.
North Pacific--Ocean and Bering Gulf of Alaska Groundfish Director, Alaska Region. Commander, Seventeenth
Sea off Alaska. Fishery. Coast Guard District.
Bering Sea and Aleutian Director, Alaska
Islands Groundfish Fisheries Science
Fishery; Snail Fishery. Center.
Pacific Ocean off Hawaii and Seamount Groundfish Director, Southwest Commander, Fourteenth
Other U.S. Insular Possessions Fishery. Region. Coast Guard District.
in the Central and Western
Pacific.
Pacific Pelagic Species Director, Southwest
Fishery; Precious Coral Center.
Fishery.
----------------------------------------------------------------------------------------------------------------
Table 3 to Sec. 600.502--U.S. Coast Guard Communications Stations and Frequencies
U.S. Coast Guard communications Radiotelephone Channel
station IRCS \1\ GMT time
Boston.............................. NMF A-E 2330-1100.
.................... B,C All.
.................... D 1100-2330.
.................... E (On request).
CAMSLANT Chesapeake (Portsmouth, VA) NMN A 2330-1100.
.................... B,C All.
.................... D 1100-2330.
.................... E (On request).
New Orleans......................... NMG A 2330-1100.
.................... B,C All.
.................... D 1100-2330.
.................... E (On request).
CAMSPAC Point Reyes (San Francisco, NMC A-D All.
CA).
.................... E (On request).
Honolulu............................ NMO A-D All.
.................... E (On request).
Kodiak.............................. NOJ A-D All.
.................... E (On request).
----------------------------------------------------------------------------------------------------------------
\1\ Carrier frequencies of duplex, high-frequency single-sideband channels are:
Letter Shore transmit Ship transmit
A.................... 4426.0 4134.0
B.................... 6501.0 6200.0
C.................... 8764.0 8240.0
D.................... 13089.0 12242.0
E.................... 17314.0 16432.0
[[Page 19412]]
Sec. 600.503 Vessel and gear identification.
(a) Vessel identification. (1) The operator of each FFV assigned an
IRCS must display that call sign amidships on both the port and
starboard sides of the deckhouse or hull, so that it is visible from an
enforcement vessel, and on an appropriate weather deck so it is visible
from the air.
(2) The operator of each FFV not assigned an IRCS, such as a small
trawler associated with a mothership or one of a pair of trawlers, must
display the IRCS of the associated vessel, followed by a numerical
suffix. (For example, JCZM-1, JCZM-2, etc., would be displayed on small
trawlers not assigned an IRCS operating with a mothership whose IRCS is
JCZM; JANP-1 would be displayed by a pair trawler not assigned an IRCS
operating with a trawler whose IRCS is JANP.)
(3) The vessel identification must be in a color in contrast to the
background and must be permanently affixed to the FFV in block Roman
alphabet letters and Arabic numerals at least 1 m in height for FFV's
over 20 m in length, and at least 0.5 m in height for all other FFV's.
(b) Navigational lights and shapes. Each FFV must display the
lights and shapes prescribed by the International Regulations for
Preventing Collisions at Sea, 1972 (TIAS 8587, and 1981 amendment TIAS
10672), for the activity in which the FFV is engaged (as described at
33 CFR part 81).
(c) Gear identification. (1) The operator of each FFV must ensure
that all deployed fishing gear that is not physically and continuously
attached to an FFV:
(i) Is clearly marked at the surface with a buoy displaying the
vessel identification of the FFV (see paragraph (a) of this section) to
which the gear belongs;
(ii) Has attached a light visible for 2 nautical miles (3.70 km) at
night in good visibility; and
(iii) Has a radio buoy.
Trawl codends passed from one vessel to another are considered
continuously attached gear and are not required to be marked.
(2) The operator of each FFV must ensure that deployed longlines,
strings of traps or pots, and gillnets are marked at the surface at
each terminal end with: (see Sec. 600.503(c)(1)(i) through (c)(1)(iii)
of this section.
(3) Additional requirements may be specified for the fishery in
which the vessel is engaged.
(4) Unmarked or incorrectly identified fishing gear may be
considered abandoned and may be disposed of in accordance with
applicable Federal regulations by any authorized officer.
(d) Maintenance. The operator of each FFV must--
(1) Keep the vessel and gear identification clearly legible and in
good repair;
(2) Ensure that nothing on the FFV obstructs the view of the
markings from an enforcement vessel or aircraft; and
(3) Ensure that the proper navigational lights and shapes are
displayed for the FFV's activity and are properly functioning.
Sec. 600.504 Facilitation of enforcement.
(a) General. (1) The owner, operator, or any person aboard any FFV
subject to this subpart must immediately comply with instructions and
signals issued by an authorized officer to stop the FFV; to move the
FFV to a specified location; and to facilitate safe boarding and
inspection of the vessel, its gear, equipment, records, and fish and
fish products on board for purposes of enforcing the Magnuson Act and
this subpart.
(2) The operator of each FFV must provide vessel position or other
information when requested by an authorized officer within the time
specified in the request.
(b) Communications equipment. (1) Each FFV must be equipped with a
VHF-FM radiotelephone station located so that it may be operated from
the wheelhouse. Each operator must maintain a continuous listening
watch on channel 16 (156.8 mHz).
(2) Each FFV must be equipped with a radiotelephone station capable
of communicating via 2182 kHz (SSB) radiotelephony and at least one set
of working frequencies identified in table 3 to Sec. 600.502
appropriate to the fishery in which the FFV is operating. Each operator
must monitor and be ready to communicate via 2182 kHz (SSB)
radiotelephone each day from 0800 GMT to 0830 GMT and 2000 to 2030 GMT,
and in preparation for boarding.
(3) FFV's that are not equipped with processing facilities and that
deliver all catches to a foreign processing vessel are exempt from the
requirements of paragraph (b)(2) of this section.
(4) FFV's with no IRCS that do not catch fish and are used as
auxiliary vessels to handle codends, nets, equipment, or passengers for
a processing vessel are exempt from the requirements of paragraphs
(b)(1) and (b)(2) of this section.
(5) The appropriate Regional Director, with the agreement of the
appropriate USCG commander, may, upon request by a foreign nation,
accept alternatives to the radio requirements of this section to
certain FFV's or types of FFV's operating in a fishery, provided they
are adequate for the communications needs of the fishery.
(c) Communications procedures. (1) Upon being approached by a USCG
vessel or aircraft, or other vessel or aircraft with an authorized
officer aboard, the operator of any FFV subject to this subpart must be
alert for communications conveying enforcement instructions. The
enforcement unit may communicate by channel 16 VHF-FM radiotelephone,
2182 kHz (SSB) radiotelephone, message block from an aircraft, flashing
light or flag signals from the International Code of Signals, hand
signal, placard, loudhailer, or other appropriate means. The following
signals, extracted from the International Code of Signals, are among
those that may be used.
(i) ``AA, AA, AA, etc.'', which is the call for an unknown station.
The signaled vessel should respond by identifying itself or by
illuminating the vessel identification required by Sec. 600.505;
(ii) ``RY-CY'', meaning ``You should proceed at slow speed, a boat
is coming to you'';
(iii) ``SQ3'', meaning ``You should stop or heave to; I am going to
board you''; and
(iv) ``L'', meaning ``You should stop your vessel instantly.''
(2) Failure of an FFV's operator to stop the vessel when directed
to do so by an authorized officer using VHF-FM radiotelephone (channel
16), 2182 kHz (SSB) radiotelephone (where required), message block from
an aircraft, flashing light signal, flaghoist, or loudhailer
constitutes a violation of this subpart.
(3) The operator of or any person aboard an FFV who does not
understand a signal from an enforcement unit and who is unable to
obtain clarification by radiotelephone or other means must consider the
signal to be a command to stop the FFV instantly.
(d) Boarding. The operator of an FFV signaled for boarding must--
(1) Monitor 2182 kHz (SSB) radiotelephone and channel 16 (156.8
mHz) VHF-FM radiotelephone;
(2) Stop immediately and lay to or maneuver in such a way as to
maintain the safety of the FFV and facilitate boarding by the
authorized officer and the boarding party or an observer;
(3) Provide the authorized officer, boarding party, or observer a
safe pilot ladder. The operator must ensure the pilot ladder is
securely attached to the FFV and meets the construction requirements of
Regulation 17, Chapter V of the International Convention for the Safety
of Life at Sea (SOLAS), 1974
[[Page 19413]]
(TIAS 9700 and 1978 Protocol, TIAS 10009), or a substantially
equivalent national standard approved by letter from the Assistant
Administrator, with agreement with the USCG. Safe pilot ladder
standards are summarized below:
(i) The ladder must be of a single length of not more than 9 m (30
ft), capable of reaching the water from the point of access to the FFV,
accounting for all conditions of loading and trim of the FFV and for an
adverse list of 15 deg.. Whenever the distance from sea level to the
point of access to the ship is more than 9 m (30 ft), access must be by
means of an accommodation ladder or other safe and convenient means.
(ii) The steps of the pilot ladder must be--
(A) Of hardwood, or other material of equivalent properties, made
in one piece free of knots, having an efficient non-slip surface; the
four lowest steps may be made of rubber of sufficient strength and
stiffness or of other suitable material of equivalent characteristics;
(B) Not less than 480 mm (19 inches) long, 115 mm (4.5 inches)
wide, and 25 mm (1 inch) in depth, excluding any non-slip device; and
(C) Equally spaced not less than 300 millimeters (12 inches) nor
more than 380 mm (15 inches) apart and secured in such a manner that
they will remain horizontal.
(iii) No pilot ladder may have more than two replacement steps that
are secured in position by a method different from that used in the
original construction of the ladder.
(iv) The side ropes of the ladder must consist of two uncovered
manila ropes not less than 60 mm (2.25 inches) in circumference on each
side (or synthetic ropes of equivalent size and equivalent or greater
strength). Each rope must be continuous, with no joints below the top
step.
(v) Battens made of hardwood, or other material of equivalent
properties, in one piece and not less than 1.80 m (5 ft 10 inches) long
must be provided at such intervals as will prevent the pilot ladder
from twisting. The lowest batten must be on the fifth step from the
bottom of the ladder and the interval between any batten and the next
must not exceed nine steps.
(vi) Where passage onto or off the ship is by means of a bulwark
ladder, two handhold stanchions must be fitted at the point of boarding
or leaving the FFV not less than 0.70 m (2 ft 3 inches) nor more than
0.80 m (2 ft 7 inches) apart, not less than 40 mm (2.5 inches) in
diameter, and must extend not less than 1.20 m (3 ft 11 inches) above
the top of the bulwark.
(4) When necessary to facilitate the boarding or when requested by
an authorized officer or observer, provide a manrope, safety line, and
illumination for the ladder; and
(5) Take such other actions as necessary to ensure the safety of
the authorized officer and the boarding party and to facilitate the
boarding and inspection.
(e) Access and records. (1) The owner and operator of each FFV must
provide authorized officers access to all spaces where work is
conducted or business papers and records are prepared or stored,
including but not limited to, personal quarters and areas within
personal quarters.
(2) The owner and operator of each FFV must provide to authorized
officers all records and documents pertaining to the fishing activities
of the vessel, including but not limited to, production records,
fishing logs, navigation logs, transfer records, product receipts,
cargo stowage plans or records, draft or displacement calculations,
customs documents or records, and an accurate hold plan reflecting the
current structure of the vessel's storage and factory spaces.
(f) Product storage. The operator of each permitted FFV storing
fish or fish products in a storage space must ensure that all non-fish
product items are neither stowed beneath nor covered by fish products,
unless required to maintain the stability and safety of the vessel.
These items include, but are not limited to, portable conveyors,
exhaust fans, ladders, nets, fuel bladders, extra bin boards, or other
movable non-product items. These items may be in the space when
necessary for safety of the vessel or crew or for storage of the
product. Lumber, bin boards, or other dunnage may be used for shoring
or bracing of product to ensure safety of crew and to prevent shifting
of cargo within the space.
Sec. 600.505 Prohibitions.
(a) It is unlawful for any person to do any of the following:
(1) Ship, transport, offer for sale, sell, purchase, import,
export, or have custody, control, or possession of any fish taken or
retained in violation of the Magnuson Act, the applicable GIFA, this
subpart, or any permit issued under this subpart;
(2) Refuse to allow an authorized officer to board an FFV for
purposes of conducting any search or inspection in connection with the
enforcement of the Magnuson Act, the applicable GIFA, this subpart, or
any other permit issued under this subpart;
(3) Assault, resist, oppose, impede, intimidate, or interfere with
any authorized officer in the conduct of any inspection or search
described in paragraph (a)(2) of this section;
(4) Resist a lawful arrest for any act prohibited by the Magnuson
Act, the applicable GIFA, this subpart, or any permit issued under this
subpart;
(5) Interfere with, delay, or prevent by any means the apprehension
or arrest of another person with the knowledge that such other person
has committed any act prohibited by the Magnuson Act, the applicable
GIFA, this subpart, or any permit issued under this subpart;
(6) Interfere with, obstruct, delay, oppose, impede, intimidate, or
prevent by any means any boarding, investigation or search, wherever
conducted, in the process of enforcing the Magnuson Act, the applicable
GIFA, this subpart, or any permit issued under this subpart;
(7) Engage in any fishing activity for which the FFV does not have
a permit as required under Sec. 600.501;
(8) Engage in any fishing activity within the EEZ without a U.S.
observer aboard the FFV, unless the requirement has been waived by the
appropriate Regional Director;
(9) Retain or attempt to retain within the EEZ, directly or
indirectly, any U.S. harvested fish, unless the FFV has a permit for
Activity Codes 4 or 6.
(10) Use any fishing vessel to engage in fishing after the
revocation, or during the period of suspension, of an applicable permit
issued under this subpart;
(11) Violate any provision of the applicable GIFA;
(12) Falsely or incorrectly complete (including by omission) a
permit application or permit form as specified in Sec. 600.501 (d) and
(k);
(13) Fail to report to the Assistant Administrator within 15 days
any change in the information contained in the permit application for a
FFV, as specified in Sec. 600.503(k);
(14) Assault, resist, oppose, impede, intimidate, or interfere with
an observer placed aboard an FFV under this subpart;
(15) Interfere with or bias the sampling procedure employed by an
observer, including sorting or discarding any catch prior to sampling,
unless the observer has stated that sampling will not occur; or tamper
with, destroy, or discard an observer's collected samples, equipment,
records, photographic film, papers, or effects without the express
consent of the observer;
(16) Prohibit or bar by command, impediment, threat, coercion, or
refusal of reasonable assistance, an observer
[[Page 19414]]
from collecting samples, conducting product recovery rate
determinations, making observations, or otherwise performing the
observer's duties;
(17) Harass or sexually harass an authorized officer or observer;
(18) Fail to provide the required assistance to an observer as
described at Sec. 600.506 (c) and (d);
(19) Fail to identify, falsely identify, fail to properly maintain,
or obscure the identification of the FFV or its gear as required by
this subpart;
(20) Falsify or fail to make, keep, maintain, or submit any record
or report required by this subpart;
(21) Fail to return to the sea or fail to otherwise treat
prohibited species as required by this subpart;
(22) Fail to report or falsely report any gear conflict;
(23) Fail to report or falsely report any loss, jettisoning, or
abandonment of fishing gear or other article into the EEZ that might
interfere with fishing, obstruct fishing gear or vessels, or cause
damage to any fishery resource or marine mammals;
(24) Continue Activity Codes 1 through 4 after those activity codes
have been canceled under Sec. 600.511;
(25) Fail to maintain health and safety standards set forth in
Sec. 600.506(d);
(26) Violate any provisions of regulations for specific fisheries
of this subpart;
(27) On a scientific research vessel, engage in fishing other than
recreational fishing authorized by applicable state, territorial, or
Federal regulations;
(28) Violate any provision of this subpart, the Magnuson Act, the
applicable GIFA, any notice issued under this subpart or any permit
issued under this subpart; or
(29) Attempt to do any of the foregoing.
(b) It is unlawful for any FFV, and for the owner or operator of
any FFV except an FFV engaged only in recreational fishing, to fish--
(1) Within the boundaries of any state, unless the fishing is
authorized by the Governor of that state as permitted by section 306(c)
of the Magnuson Act to engage in a joint venture for processing and
support with U.S. fishing vessels in the internal waters of that state;
or
(2) Within the EEZ, or for any anadromous species or continental
shelf fishery resources beyond the EEZ, unless the fishing is
authorized by, and conducted in accordance with, a valid permit issued
under Sec. 600.501.
Sec. 600.506 Observers.
(a) General. To carry out such scientific, compliance monitoring,
and other functions as may be necessary or appropriate to carry out the
purposes of the Magnuson Act, the appropriate Regional or Science and
Research Director (see table 2 to Sec. 600.502) may assign U.S.
observers to FFV's. Except as provided for in section 201(i)(2) of the
Magnuson Act, no FFV may conduct fishing operations within the EEZ
unless a U.S. observer is aboard.
(b) Effort plan. To ensure the availability of an observer as
required by this section, the owners and operators of FFV's wanting to
fish within the EEZ will submit to the appropriate Regional Director or
Science and Research Director; and also to the Chief, Office of
Enforcement, NMFS, Silver Spring, MD., a schedule of fishing effort 30
days prior to the beginning of each quarter. A quarter is a time period
of 3 consecutive months beginning January 1, April 1, July 1, and
October 1 of each year. The schedule will contain the name and IRCS of
each FFV intending to fish within the EEZ during the upcoming quarter,
and each FFV's expected date of arrival and expected date of departure.
(1) The appropriate Regional or Science and Research Director must
be notified immediately of any substitution of vessels or any
cancellation of plans to fish in the EEZ for FFV's listed in the effort
plan required by this section.
(2) If an arrival date of an FFV will vary more than 5 days from
the date listed in the quarterly schedule, the appropriate Regional or
Science and Research Director must be notified at least 10 days in
advance of the rescheduled date of arrival. If the notice required by
this paragraph (b)(2) is not given, the FFV may not engage in fishing
until an observer is available and has been placed aboard the vessel or
the requirement has been waived by the appropriate Regional or Science
and Research Director.
(c) Assistance to observers. To assist the observer in the
accomplishment of his or her assigned duties, the owner and operator of
an FFV to which an observer is assigned must--
(1) Provide, at no cost to the observer or the United States,
accommodations for the observer aboard the FFV that are equivalent to
those provided to the officers of that vessel;
(2) Cause the FFV to proceed to such places and at such times as
may be designated by the appropriate Regional or Science and Research
Director for the purpose of embarking and debarking the observer;
(3) Allow the observer to use the FFV's communications equipment
and personnel upon demand for the transmission and receipt of messages;
(4) Allow the observer access to and use of the FFV's navigation
equipment and personnel upon demand to determine the vessel's position;
(5) Allow the observer free and unobstructed access to the FFV's
bridge, trawl, or working decks, holding bins, processing areas,
freezer spaces, weight scales, cargo holds and any other space that may
be used to hold, process, weigh, or store fish or fish products at any
time;
(6) Allow the observer to inspect and copy the FFV's daily log,
communications log, transfer log, and any other log, document, notice,
or record required by these regulations;
(7) Provide the observer copies of any records required by these
regulations upon demand;
(8) Notify the observer at least 15 minutes before fish are brought
on board or fish or fish products are transferred from the FFV to allow
sampling the catch or observing the transfer, unless the observer
specifically requests not to be notified; and
(9) Provide all other reasonable assistance to enable the observer
to carry out his or her duties.
(d) Health and safety standards. All foreign fishing vessels to
which an observer is deployed must maintain, at all times that the
vessel is in the EEZ, the following:
(1) At least one working radar;
(2) Functioning navigation lights as required by international law;
(3) A watch on the bridge by appropriately trained and experienced
personnel while the vessel is underway;
(4) Lifeboats and/or inflatable life rafts with a total carrying
capacity equal to or greater than the number of people aboard the
vessel. Lifeboats and inflatable life rafts must be maintained in good
working order and be readily available;
(5) Life jackets equal or greater in number to the total number of
persons aboard the vessel. Life jackets must be stowed in readily
accessible and plainly marked positions throughout the vessel, and
maintained in a state of good repair;
(6) At least one ring life buoy for each 25 ft (7.6 m) of vessel
length, equipped with automatic water lights. Ring life buoys must have
an outside diameter of not more than 32 inches (81.3 cm) nor less than
30 inches (76.2 cm), and must be maintained in a state of good repair.
Ring life buoys must be readily available, but not positioned so they
pose a threat of entanglement in work areas. They must be secured in
such a way that they can be easily cast loose in the event of an
emergency;
(7) At least one VHF-FM radio with a functioning channel 16 (156.8
mHz),
[[Page 19415]]
International Distress, Safety and Calling Frequency, and one
functioning AM radio (SSB-Single Side Band) capable of operating at
2182 kHz (SSB). Radios will be maintained in a radio room, chartroom,
or other suitable location;
(8) At least one Emergency Position Indicating Radio Beacon
(EPIRB), approved by the USCG for offshore commercial use, stowed in a
location so as to make it readily available in the event of an
emergency;
(9) At least six hand-held, rocket-propelled, parachute, red-flare
distress signals, and three orange-smoke distress signals stowed in the
pilothouse or navigation bridge in portable watertight containers;
(10) All lights, shapes, whistles, foghorns, fog bells and gongs
required by and maintained in accordance with the International
Regulations for Preventing Collisions at Sea; and
(11) Clean and sanitary conditions in all living spaces, food
service and preparation areas and work spaces aboard the vessel.
(e) Observer transfers. (1) The operator of the FFV must ensure
that transfers of observers at sea via small boat or raft are carried
out during daylight hours as weather and sea conditions allow, and with
the agreement of the observer involved. The FFV operator must provide
the observer 3 hours advance notice of at-sea transfers, so that the
observer may collect personal belongings, equipment, and scientific
samples.
(2) The FFV's involved must provide a safe pilot ladder and conduct
the transfer according to the procedures of Sec. 600.506(d) to ensure
the safety of the during the transfer.
(3) An experienced crew member must assist the observer in the
small boat or raft in which the transfer is made.
(f) Supplementary observers. In the event funds are not available
from Congressional appropriations of fees collected to assign an
observer to a foreign fishing vessel, the appropriate Regional or
Science and Research Director will assign a supplementary observer to
that vessel. The costs of supplementary observers will be paid for by
the owners and operators of foreign fishing vessels as provided for in
paragraph (h) of this section.
(g) Supplementary observer authority and duties. (1) A
supplementary observer aboard a foreign fishing vessel has the same
authority and must be treated in all respects as an observer who is
employed by NMFS, either directly or under contract.
(2) The duties of supplementary observers and their deployment and
work schedules will be specified by the appropriate Regional or Science
and Research Director.
(3) All data collected by supplementary observers will be under the
exclusive control of the Assistant Administrator.
(h) Supplementary observer payment--(1) Method of payment. The
owners and operators of foreign fishing vessels must pay directly to
the contractor the costs of supplementary observer coverage. Payment
must be made to the contractor supplying supplementary observer
coverage either by letter of credit or certified check drawn on a
federally chartered bank in U.S. dollars, or other financial
institution acceptable to the contractor. The letter of credit used to
pay supplementary observer fees to contractors must be separate and
distinct from the letter of credit required by Sec. 600.518(b)(2).
Billing schedules will be specified by the terms of the contract
between NOAA and the contractors. Billings for supplementary observer
coverage will be approved by the appropriate Regional or Science and
Research Director and then transmitted to the owners and operators of
foreign fishing vessels by the appropriate designated representative.
Each country will have only one designated representative to receive
observer bills for all vessels of that country, except as provided for
by the Assistant Administrator. All bills must be paid within 10
working days of the billing date. Failure to pay an observer bill will
constitute grounds to revoke fishing permits. All fees collected under
this section will be considered interim in nature and subject to
reconciliation at the end of the fiscal year in accordance with
paragraph (h)(4) of this section and Sec. 600.518(d).
(2) Contractor costs. The costs charged for supplementary observer
coverage to the owners and operators of foreign fishing vessels may not
exceed the costs charged to NMFS for the same or similar services,
except that contractors may charge to the owners and operators of
foreign fishing vessels an additional fee to cover the administrative
costs of the program not ordinarily part of contract costs charged to
NMFS. The costs charged foreign fishermen for supplementary observers
may include, but are not limited to the following:
(i) Salary and benefits, including overtime, for supplementary
observers;
(ii) The costs of post-certification training required by paragraph
(j)(2) of this section;
(iii) The costs of travel, transportation, and per diem associated
with deploying supplementary observers to foreign fishing vessels
including the cost of travel, transportation, and per diem from the
supplementary observer's post of duty to the point of embarkation to
the foreign fishing vessel, and then from the point of disembarkation
to the post of duty from where the trip began. For the purposes of
these regulations, the appropriate Regional or Science and Research
Director will designate posts of duty for supplementary observers;
(iv) The costs of travel, transportation, and per diem associated
with the debriefing following deployment of a supplementary observer by
NMFS officials; and
(v) The administrative and overhead costs incurred by the
contractor and, if appropriate, a reasonable profit.
(3) NMFS costs. The owners and operators of foreign fishing vessels
must also pay to NMFS as part of the surcharge required by section
201(i)(4) of the Magnuson Act, the following costs:
(i) The costs of certifying applicants for the position of
supplementary observer;
(ii) The costs of any equipment, including safety equipment,
sampling equipment, operations manuals, or other texts necessary to
perform the duties of a supplementary observer. The equipment will be
specified by the appropriate Regional or Science and Research Director
according to the requirements of the fishery to which the supplementary
observer will be deployed;
(iii) The costs associated with communications with supplementary
observers for transmission of data and routine messages;
(iv) For the purposes of monitoring the supplementary observer
program, the costs for the management and analysis of data;
(v) The costs for data editing and entry;
(vi) Any costs incurred by NMFS to train, deploy or debrief a
supplementary observer; and
(vii) The cost for U.S. Customs inspection for supplementary
observers disembarking after deployment.
(4) Reconciliation. Fees collected by the contractor in excess of
the actual costs of supplementary observer coverage will be refunded to
the owners and operators of foreign fishing vessels, or kept on deposit
to defray the costs of future supplementary observer coverage. Refunds
will be made within 60 days after final costs are determined and
approved by NMFS.
[[Page 19416]]
(i) Supplementary observer contractors--(1) Contractor eligibility.
Supplementary observers will be obtained by NMFS from persons or firms
having established contracts to provide NMFS with observers. In the
event no such contract is in place, NMFS will use established,
competitive contracting procedures to select persons or firms to
provide supplementary observers. The services supplied by the
supplementary observer contractors will be as described within the
contract and as specified below.
(2) Supplementary observer contractors must submit for the approval
of the Assistant Administrator the following:
(i) A copy of any contract, including all attachments, amendments,
and enclosures thereto, between the contractor and the owners and
operators of foreign fishing vessels for whom the contractor will
provide supplementary observer services;
(ii) All application information for persons whom the contractor
desires to employ as certified supplementary observers;
(iii) Billing schedules and billings to the owners and operators of
foreign fishing vessels for further transmission to the designated
representative of the appropriate foreign nation; and
(iv) All data on costs.
(j) Supplementary observers--certification, training--(1)
Certification. The appropriate Regional or Science and Research
Director will certify persons as qualified for the position of
supplementary observer once the following conditions are met:
(i) The candidate is a citizen or national of the United States.
(ii) The candidate has education or experience equivalent to the
education or experience required of persons used as observers by NMFS
as either Federal personnel or contract employees. The education and
experience required for certification may vary according to the
requirements of managing the foreign fishery in which the supplementary
observer is to be deployed. Documentation of U.S. citizenship or
nationality, and education or experience will be provided from personal
qualification statements on file with NMFS contractors who provide
supplementary observer services, and will not require the submission of
additional information to NMFS.
(2) Training. Prior to deployment to foreign fishing vessels,
certified supplementary observers must also meet the following
conditions:
(i) Each certified supplementary observer must satisfactorily
complete a course of training approved by the appropriate Regional or
Science and Research Director as equivalent to that received by persons
used as observers by NMFS as either Federal personnel or contract
employees. The course of training may vary according to the foreign
fishery in which the supplementary observer is to be deployed.
(ii) Each certified supplementary observer must agree in writing to
abide by standards of conduct as set forth in Department of Commerce
Administrative Order 202-735 (as provided by the contractor).
(k) Supplementary observer certification suspension or revocation.
(1) Certification of a supplementary observer may be suspended or
revoked by the Assistant Administrator under the following conditions:
(i) A supplementary observer fails to perform the duties specified
in paragraph (g)(2) of this section.
(ii) A supplementary observer fails to abide by the standards of
conduct described by Department of Commerce Administrative Order 202-
735.
(2) The suspension or revocation of the certification of a
supplementary observer by the Assistant Administrator may be based on
the following:
(i) Boarding inspection reports by authorized officers of the USCG
or NMFS, or other credible information, that indicate a supplementary
observer has failed to abide by the established standards of conduct;
or
(ii) An analysis by NMFS of the data collected by a supplementary
observer indicating improper or incorrect data collection or recording.
The failure to properly collect or record data is sufficient to justify
decertification of supplementary observers; no intent to defraud need
be demonstrated.
(3) The Assistant Administrator will notify the supplementary
observer, in writing, of the Assistant Administrator's intent to
suspend or revoke certification, and the reasons therefor, and provide
the supplementary observer a reasonable opportunity to respond. If the
Assistant Administrator determines that there are disputed questions of
material fact, then the Assistant Administrator may in this respect
appoint an examiner to make an informal fact-finding inquiry and
prepare a report and recommendations.
Sec. 600.507 Recordkeeping.
(a) General. The owner and operator of each FFV must maintain
timely and accurate records required by this section as modified by the
regulations for the fishery in which the FFV is engaged.
(1) The owner and operator of each FFV must maintain all required
records in English, based on Greenwich mean time (GMT) unless otherwise
specified in the regulation, and make them immediately available for
inspection upon the request of an authorized officer or observer.
(2) The owner and operator of each FFV must retain all required
records on board the FFV whenever it is in the EEZ, for 3 years after
the end of the permit period.
(3) The owner and operator of each FFV must retain the required
records and make them available for inspection upon the request of an
authorized officer at any time during the 3 years after the end of the
permit period, whether or not such records are on board the vessel.
(4) The owner and operator of each FFV must provide to the
Assistant Administrator, in the form and at the times prescribed, any
other information requested that the Assistant Administrator determines
is necessary to fulfill the fishery conservation, management and
enforcement purposes of the Magnuson Act.
(b) Communications log. The owner and operator of each FFV must
record in a separate communications log, at the time of transmittal,
the time and content of each notification made under Sec. 600.504.
(c) Transfer log. Except for the transfer of unsorted, unprocessed
fish via codend from a catching vessel to a processing vessel (Activity
Code 2 or 4), the owner and operator of each FFV must record, in a
separate transfer log, each transfer or receipt of any fish or fishery
product, including quantities transferred or offloaded outside the EEZ.
The operator must record in the log within 12 hours of the completion
of the transfer:
(1) The time and date (GMT) and location (in geographic
coordinates) the transfer began and was completed;
(2) The product weight, by species and product (use species and
product codes), of all fish transferred, to the nearest 0.01 mt; and
(3) The name, IRCS, and permit number of both the FFV offloading
the fish and the FFV receiving the fish.
(d) Daily fishing log. (1) The owner or operator of each FFV
authorized to catch fish (Activity Code 1) must maintain a daily
fishing log of the effort, catch and production of the FFV, as modified
by paragraph (d)(2) of this section and the regulations for the fishery
in which the FFV is engaged. The operator must maintain on a daily and
cumulative basis for the permit period a separate log for each fishery
(see table 2 to Sec. 600.502) in which the FFV is engaged according to
this section
[[Page 19417]]
and in the format specified in the instructions provided with the
permit or other format authorized under paragraph (k) of this section.
Daily effort entries are required for each day the vessel conducts
fishing operations within the EEZ. Daily entries are not required
whenever the FFV is in port or engaged in a joint venture in the
internal waters of a state. Each page of log may contain entries
pertaining to only one day's fishing operations or one gear set,
whichever is longer.
(2) The owner or operator of each FFV authorized to catch fish
(Activity Code 1) and that delivers all catches to a processing vessel,
must maintain only ``SECTION ONE--EFFORT,'' of the daily fishing log,
provided the processing vessel maintains a daily consolidated fishing
log as described in paragraphs (f) and (g) of this section.
(e) Daily fishing log--contents. The daily fishing log must contain
the following information, as modified by paragraph (d)(2) of this
section and the regulations for the fishery in which the FFV is
engaged, and be completed according to the format and instructions
provided with the permit or other format authorized under paragraph (k)
of this section.
(1) ``SECTION ONE--EFFORT'' must contain on a daily basis--
(i) A consecutive page number, beginning with the first day the
vessel started fishing operations within the EEZ and continuing
throughout the log;
(ii) The date (based on GMT);
(iii) The FFV's name;
(iv) The FFV's IRCS;
(v) The FFV's U.S. permit number;
(vi) The FFV's noon (1200 GMT) position in geographic coordinates;
and
(vii) The master or operator's signature or title.
(2) ``SECTION ONE--EFFORT'' must contain, for each trawl or set, as
appropriate to the gear type employed--
(i) The consecutive trawl or set number, beginning with the first
set of the calendar year;
(ii) The fishing area in which the trawl or set was completed;
(iii) The gear type;
(iv) The time the gear was set;
(v) The position of the set;
(vi) The course of the set;
(vii) The sea depth;
(viii) The depth of the set;
(ix) The duration of the set;
(x) The hauling time;
(xi) The position of the haul;
(xii) The number of pots or longline units (where applicable);
(xiii) The average number of hooks per longline unit (where
applicable);
(xiv) The trawl speed (where applicable);
(xv) The mesh size of the trawl's codend (where applicable); and
(xvi) The estimated total weight of the catch for the trawl of set,
to at least the nearest metric ton round weight.
(3) ``SECTION TWO--CATCH'' must contain, for each trawl or set--
(i) The consecutive set or trawl number from ``SECTION ONE'';
(ii) The catch of each allocated species or species group to at
least the nearest 0.1 mt round weight;
(iii) The prohibited species catch to at least the nearest 0.1 mt
round weight or by number, as required by the regulations for the
fishery in which the FFV is engaged; and
(iv) The species code of each marine mammal caught and its
condition when released.
(4) ``SECTION TWO--CATCH'' must contain, on a daily basis--
(i) The species codes for all allocated or prohibited species or
species groups caught;
(ii) For each allocated species--the amount, to at least the
nearest 0.1 mt, and the daily disposition, either processed for human
consumption, used for fishmeal, or discarded; the daily catch by
fishing area; the daily catch for all fishing areas; and the cumulative
total catch;
(iii) For the total catch of allocated species--the amount to at
least the nearest 0.1 mt and the daily disposition, daily total catch
by fishing area, daily total catch for all fishing areas, and
cumulative total catch; and
(iv) The catch by fishing area, daily total, and cumulative total
of each prohibited species.
(5) ``SECTION THREE--PRODUCTION'' must contain, on a daily basis,
for each allocated species caught and product produced--
(i) The product by species code and product type;
(ii) The daily product recovery rate of each species and product;
(iii) The daily total product produced by species to at least the
nearest 0.01 mt;
(iv) The cumulative total of each product to at least the nearest
0.01 mt;
(v) The cumulative amount of product transferred;
(vi) The balance of product remaining aboard the FFV;
(vii) The total daily amount, cumulative amount, transferred
product and balance of frozen product aboard the FFV to the nearest
0.01 mt; and
(viii) Transferred amount and balance of fishmeal and fish oil
aboard to at least the nearest 0.01 mt.
(f) Daily consolidated fishing log. The owner or operator of each
FFV that receives unsorted, unprocessed fish from foreign catching
vessels (Activity Code 2) for processing must maintain a daily
consolidated fishing log of the effort, catch and production of its
associated foreign catching vessels and the processing vessel, as
modified by the regulations for the fishery in which the FFV is
engaged. This log is separate and in addition to any log required by
paragraphs (d) and (e) of this section. The owner or operator must
maintain a separate log for each fishery in which the FFV is engaged
(see table 2 of Sec. 600.504) on a daily and cumulative basis for the
permit period according to this section and in the format specified in
the instructions provided with the permit or other format authorized by
paragraph (k) of this section. Each page of the log may contain entries
pertaining to only 1 day's fishing operations.
(g) Daily consolidated fishing log--contents. Daily consolidated
fishing logs must contain the following information, as modified by the
fishery in which the vessel is engaged, and be completed according to
the format and instructions provided with the permit or other format
authorized under paragraph (k) of this section.
(1) ``SECTION ONE--EFFORT'' must contain, on a daily basis, that
information required in paragraph (e)(1) of this section.
(2) ``SECTION TWO--CATCH'' must contain for each foreign catching
vessel, on a daily basis and by area--
(i) The name and IRCS of the foreign catching vessel;
(ii) The fishing area number from which the fish were caught (where
the foreign catching vessel caught fish in more than one area, a daily
entry for each area must be made);
(iii) The receipts of each allocated species or species group, to
at least the nearest 0.1 mt round weight;
(iv) The receipts of each prohibited species and species group to
at least the nearest 0.1 mt round weight, or by number, as required by
the fishery in which the FFV is engaged; and
(v) The species code of each marine mammal received and its
condition when released.
(3) ``SECTION TWO--CATCH''--must contain, on a daily basis--
(i) The species codes for all allocated or prohibited species or
species groups received;
(ii) For each allocated species--the amount, to at least the
nearest 0.1 mt, and the daily disposition, either processed for human
consumption, used for fishmeal, or discarded; the daily receipts by
fishing area; the daily catch for all fishing areas; and the cumulative
total catch;
(iii) For the total receipts of allocated species--the amount, to
at least the
[[Page 19418]]
nearest tenth of a metric ton (0.1 mt), and the daily disposition,
daily total receipts by fishing area, daily total receipts for all
fishing areas, and cumulative total receipts; and
(iv) The receipts by fishing area, daily total and cumulative total
of each prohibited species.
(4) ``SECTION THREE--PRODUCTION'' must contain, on a daily basis,
for each allocated species received and product produced that
information required in paragraph (e)(5) of this section.
(h) Daily joint venture log. The operator of each FFV that receives
U.S.-harvested fish from U.S. fishing vessels in a joint venture
(Activity Code 4) must maintain a daily joint venture log of the
effort, catch and production of its associated U.S. fishing vessels and
the processing vessel as modified by the regulations for the fishery in
which the FFV is engaged. This log is separate and in addition to any
log required by paragraphs (d) and (f) of this section. The operator
must maintain a separate log for each fishery in which the FFV is
engaged, on a daily and cumulative basis, according to this section and
in the format specified in the instructions provided with the permit or
other format authorized under paragraph (k) of this section. Receipts
of fish caught outside the EEZ must be included. Each page of the log
may contain entries pertaining to only one day's fishing operations.
(i) Daily joint venture log--contents. Daily joint venture logs
must contain the following information, as modified by the fishery in
which the vessel is engaged, and be completed according to the format
and instructions provided with the permit or other format authorized
under paragraph (k) of this section.
(1) ``SECTION ONE--EFFORT'' must contain, on a daily basis, that
information required in paragraph (e)(1) of this section.
(2) ``SECTION ONE--EFFORT'' must contain for each receipt of a
codend--
(i) The consecutive codend number, beginning with the first codend
received for the calendar year;
(ii) The name of the U.S. fishing vessel the codend was received
from;
(iii) The fishing area where the codend was received;
(iv) The time the codend was received;
(v) The position the codend was received; and
(vi) The estimated weight of the codend to at least the nearest
metric ton round weight.
(3) ``SECTION TWO--CATCH'' must contain, for each codend received--
(i) The consecutive codend number from ``SECTION ONE'';
(ii) The receipts of each authorized species or species group and
its disposition, either processed for human consumption, used for
fishmeal, discarded, or returned to the U.S. fishing vessel, to at
least the nearest 0.1 mt round weight;
(iii) The estimated receipts of each prohibited species or species
group and its disposition, either discarded or returned to the U.S.
fishing vessel if authorized in the fishery in which the U.S. vessel is
engaged, to at least the nearest 0.1 mt round weight; and
(iv) The species code of each marine mammal received and its
condition when released.
(4) ``SECTION TWO--CATCH'' must contain on a daily basis--
(i) The species codes of all authorized or prohibited species or
species groups received;
(ii) The daily disposition, as described in paragraph (i)(3)(ii) of
this section, daily total, and cumulative total receipts of each
authorized species or species groups;
(iii) The daily disposition, daily total and cumulative total
receipts of all authorized species or species groups; and
(iv) The daily and cumulative total receipts of prohibited species
groups and their disposition as described in paragraph (i)(3)(iii) of
this section.
(5) ``SECTION THREE--PRODUCTION'' must contain, on a daily basis,
for each authorized species or species group received and product
produced, that information required in paragraph (e)(5) of this
section.
(j) Daily log maintenance. The logs required by paragraphs (e)
through (i) of this section must be maintained separately for each
fishery (see table 2 to Sec. 600.502).
(1) The effort section (all of ``SECTION ONE'') of the daily logs
must be updated within 2 hours of the hauling or receipt time. The
catch or receipt by trawl or set (``SECTION TWO'') must be entered
within 12 hours of the hauling or receipt time. The daily and
cumulative total catch or receipts (``SECTION TWO'') and the production
portion (``SECTION THREE'') of the log must be updated within 12 hours
of the end of the day on which the catch was taken. The date of catch
is the day and time (GMT) the gear is hauled.
(2) Entries for total daily and cumulative catch or receipt weights
(disposition ``C'' or ``M'') must be based on the most accurate method
available to the vessel, either scale round weights or factory weights
converted to round weights. Entries for daily and cumulative weights of
discarded or returned fish (disposition ``D'' or ``R'') must be based
on the most accurate method available to the vessel, either actual
count, scale round weight, or estimated deck weights. Entries for
product weights must be based on the number of production units (pans,
boxes, blocks, trays, cans, or bags) and the average weight of the
production unit, with reasonable allowances for water added. Allowances
for water added cannot exceed 5 percent of the unit weight. Product
weights cannot be based on the commercial or arbitrary wholesale weight
of the product, but must be based on the total actual weight of the
product as determined by representative samples.
(3) The owner or operator must make all entries in indelible ink,
with corrections to be accomplished by lining out and rewriting, rather
than erasure.
(k) Alternative log formats. As an alternative to the use of the
specific formats provided, a Nation may submit a proposed log format
for FFV's of that Nation for a general type of fishery operation in a
fishery (i.e., joint venture operations) to the appropriate Regional
Director and the USCG commander (see tables 1 and 2 to Sec. 600.502).
With the agreement of the USCG commander, the Regional Director may
authorize the use of that log format for vessels of the requesting
Nation.
Sec. 600.508 Fishing operations.
(a) Catching. Each FFV authorized for activity code 1 may catch
fish. An FFV may retain its catch of any species or species group for
which there is an unfilled national allocation. All fish caught will be
counted against the national allocation, even if the fish are
discarded, unless exempted by the regulations of the fishery in which
the FFV is engaged. Catching operations may be conducted as specified
by the regulations of the fishery in which the FFV is engaged and as
modified by the FFV's permit.
(b) Scouting. Each FFV authorized for Activity Codes 1 through 6
may scout for fish. Scouting may be conducted only in the fisheries
area authorized by the scouting vessel's permit and under such other
circumstances as may be designated in this subpart or the permit.
(c) Processing. Each FFV with Activity Code 1 or 2 may process
fish. Processing may only be conducted whenever and wherever catching
operations for FFV's of that Nation are permitted, whenever and
wherever joint venture operations are authorized by an FFV's permit
under Activity Code 4, and under such other circumstances as
[[Page 19419]]
may be designated in this subpart or the permit.
(d) Support. Each FFV with Activity Codes 1, 2, 3, 5, or 8 may
support other permitted FFV's. Each FFV with Activity Codes 4 or 6 may
support U.S. vessels. Support operations may be conducted only in the
fisheries areas authorized by the supporting vessel's permit, and under
such other circumstances as may be designated in this subpart or the
permit.
(e) Joint ventures. Each FFV with Activity Code 4 in addition to
Activity Codes 1 or 2 may also conduct operations with U.S. fishing
vessels. These joint venture operations with U.S. fishing vessels may
be conducted throughout the EEZ, and under such other circumstances as
may be designated in these regulations or the permit. FFV's with
activity code 4 may continue operations assisting U.S. fishing vessels,
despite closures under Sec. 600.511(a).
(f) Each FFV authorized by the Governor of a state under section
306(c) of the Magnuson Act may engage in processing and support of U.S.
fishing vessels within the internal waters of that state, in compliance
with terms and conditions set by the authorizing Governor.
Sec. 600.509 Prohibited species.
(a) The owner or operator of each FFV must minimize its catch or
receipt of prohibited species.
(b) After allowing for sampling by an observer (if any), the owner
or operator of each FFV must sort its catch of fish received as soon as
possible and return all prohibited species and species parts to the sea
immediately with a minimum of injury, regardless of condition, unless a
different procedure is specified by the regulations for the fishery in
which the FFV is engaged. All prohibited species must be recorded in
the daily fishing log and other fishing logs as specified by the
regulations for the fishery in which the FFV is engaged.
(c) All species of fish that an FFV has not been specifically
allocated or authorized under this subpart to retain, including fish
caught or received in excess of any allocation or authorization, are
prohibited species.
(d) It is a rebuttable presumption that any prohibited species or
species part found on board an FFV was caught and retained in violation
of this section.
Sec. 600.510 Gear avoidance and disposal.
(a) Vessel and gear avoidance. (1) FFV's arriving on fishing
grounds where fishing vessels are already fishing or have set their
gear for that purpose must ascertain the position and extent of gear
already placed in the sea and must not place themselves or their
fishing gear so as to interfere with or obstruct fishing operations
already in progress. Vessels using mobile gear must avoid fixed fishing
gear.
(2) The operator of each FFV must maintain on its bridge a current
plot of broadcast fixed-gear locations for the area in which it is
fishing, as required by the regulations for the fishery in which the
FFV is engaged.
(b) Gear conflicts. The operator of each FFV that is involved in a
conflict or that retrieves the gear of another vessel must immediately
notify the appropriate USCG commander identified in tables 1 and 2 to
Sec. 600.502 and request disposal instructions. Each report must
include:
(1) The name of the reporting vessel;
(2) A description of the incident and articles retrieved, including
the amount, type of gear, condition, and identification markings;
(3) The location of the incident; and
(4) The date and time of the incident.
(c) Disposal of fishing gear and other articles. (1) The operator
of an FFV in the EEZ may not dump overboard, jettison or otherwise
discard any article or substance that may interfere with other fishing
vessels or gear, or that may catch fish or cause damage to any marine
resource, including marine mammals and birds, except in cases of
emergency involving the safety of the ship or crew, or as specifically
authorized by communication from the appropriate USCG commander or
other authorized officer. These articles and substances include, but
are not limited to, fishing gear, net scraps, bale straps, plastic
bags, oil drums, petroleum containers, oil, toxic chemicals or any
manmade items retrieved in an FFV's gear.
(2) The operator of an FFV may not abandon fishing gear in the EEZ.
(3) If these articles or substances are encountered, or in the
event of accidental or emergency placement into the EEZ, the vessel
operator must immediately report the incident to the appropriate USCG
Commander indicated in tables 1 and 2 to Sec. 600.502, and give the
information required in paragraph (b) of this section.
Sec. 600.511 Fishery closure procedures.
(a) Activity Codes 1 and 2 for a fishery are automatically canceled
in the following cases, unless otherwise specified by regulations
specific to a fishery, when--
(1) The OY for any allocated species or species group has been
reached in that fishery;
(2) The TALFF or catch allowance for any allocated species or
species group has been reached in that fishery;
(3) The foreign nation's allocation for any allocated species or
species group has been reached; or
(4) The letter of credit required in Sec. 600.518(b)(2) is not
established and maintained.
(b) Activity Code 4 is automatically canceled when--
(1) The OY for a species with a JVP amount is reached;
(2) The JVP amount for a species or species group is reached; or
(3) The letter of credit required in Sec. 600.518(b)(2) is not
established and maintained.
(c) Notification. (1) The Regional Director is authorized to close
a fishery on behalf of NMFS. The Regional Director will notify each
FFV's designated representative of closures.
(2) If possible, notice will be given 48 hours before the closure.
However, each Nation and the owners and operators of all FFV's of that
Nation are responsible for ending fishing operations when an allocation
is reached.
(d) Catch reconciliation. Vessel activity reports, U.S.
surveillance observations, observer reports, and foreign catch and
effort reports will be used to make the determination listed in
paragraphs (a) and (b) of this section. If NMFS estimates of catch or
other values made during the season differ from those reported by the
foreign fleets, efforts may be initiated by the designated
representative of each Nation to resolve such differences with NMFS.
If, however, differences still persist after such efforts have been
made, NMFS estimates will be the basis for decisions and will prevail.
(e) Duration. Any closure under this section will remain in effect
until an applicable new or increased allocation or JVP becomes
available or the letter of credit required by Sec. 600.518(b)(2) is
reestablished.
Sec. 600.512 Scientific research.
(a) Scientific research activity. Persons planning to conduct
scientific research activities in the EEZ that may be confused with
fishing are encouraged to submit to the appropriate Regional Director,
Director, or designee, 60 days or as soon as practicable prior to its
start, a scientific research plan for each scientific cruise. The
Regional Director, Director, or designee will acknowledge notification
of scientific research activity by issuing to the operator or master of
that vessel, or to the sponsoring institution, a letter of
acknowledgment. This letter of acknowledgment is separate and
[[Page 19420]]
distinct from any permit required under any other applicable law. If
the Regional Director, Director, or designee, after review of a
research plan, determines that it does not constitute scientific
research activity, but rather fishing, the Regional Director, Director,
or designee will inform the applicant as soon as practicable and in
writing. The Regional Director, Director, or designee may also make
recommendations to revise the research plan to make the cruise
acceptable as scientific research activity. In order to facilitate
identification of activity as scientific research, persons conducting
scientific research activities are advised to carry a copy of the
scientific research plan and the letter of acknowledgment on board the
scientific research vessel. Activities conducted in accordance with a
scientific research plan acknowledged by such a letter are presumed to
be scientific research activities. The presumption may be overcome by
showing that an activity does not fit the definition of scientific
research activity or is outside the scope of the scientific research
plan.
(b) Reports. Persons conducting scientific research are requested
to submit a copy of any cruise report or other publication created as a
result of the cruise, including the amount, composition, and
disposition of their catch, to the appropriate Science and Research
Director.
Sec. 600.513 Recreational fishing.
(a) Foreign vessels conducting recreational fishing must comply
only with this section, and Secs. 600.10, 600.504(a)(1), and 600.505
(as applicable). Such vessels may conduct recreational fishing within
the EEZ and within the boundaries of a state. Any fish caught may not
be sold, bartered, or traded.
(b) The owners or operator and any other person aboard any foreign
vessel conducting recreational fishing must comply with any Federal
laws or regulations applicable to the domestic fishery while in the
EEZ, and any state laws or regulations applicable while in state
waters.
Sec. 600.514 Relation to other laws.
(a) Persons affected by these regulations should be aware that
other Federal and state statutes may apply to their activities.
(b) Fishing vessel operators must exercise due care in the conduct
of fishing activities near submarine cables. Damage to su
FR Doc. 96-9988 Magnuson Act Provisions; Consolidation and Update of Regulations
bmarine cables
resulting from intentional acts or from the failure to exercise due
care in the conduct of fishing operations subjects the fishing vessel
operator to enforcement action under the International Convention for
the Protection of Submarine Cables, and to the criminal penalties
prescribed by the Submarine Cable Act (47 U.S.C. 21) and other laws
that implement that Convention. Fishing vessel operators also should be
aware that the Submarine Cable Act prohibits fishing operations at a
distance of less than 1 nautical mile (1.85 km) from a vessel engaged
in laying or repairing a submarine cable; or at a distance of less than
0.25 nautical mile (0.46 km) from a buoy or buoys intended to mark the
position of a cable when being laid, or when out of order, or broken.
Sec. 600.515 Interpretation of 16 U.S.C. 1857(4).
Section 307(4) of the Magnuson Act prohibits any fishing vessel
other than a vessel of the United States (foreign fishing vessel) from
operating in the EEZ if all of the fishing gear on board the vessel is
not stowed in compliance with that section ``unless such vessel is
authorized to engage in fishing in the area in which the vessel is
operating.'' If such a vessel has a permit authorization that is
limited to fishing activities other than catching, taking or harvesting
(such as support, scouting or processing activities), it must have all
of its fishing gear stowed at all times while it is in the EEZ. If such
a vessel has a permit authorization to engage in catching, taking or
harvesting activities, but such authorization is limited to a specific
area within the EEZ, and/or to a specific period of time, the vessel
must have all of its fishing gear stowed while it is in the EEZ, except
when it is in the specific area authorized, and/or during the specific
period of time authorized.
Sec. 600.516 Total allowable level of foreign fishing (TALFF).
(a) The TALFF, if any, with respect to any fishery subject to the
exclusive fishery management authority of the United States, is that
portion of the OY of such fishery that will not be caught by vessels of
the United States.
(b) Each specification of OY and each assessment of the anticipated
U.S. harvest will be reviewed during each fishing season. Adjustments
to TALFF's will be made based on updated information relating to status
of stocks, estimated and actual performance of domestic and foreign
fleets, and other relevant factors.
(c) Specifications of OY and the initial estimates of U.S. harvests
and TALFF's at the beginning of the relevant fishing year will be
published in the Federal Register. Adjustments to those numbers will be
published in the Federal Register upon occasion or as directed by
regulations implementing FMPs. For current apportionments, contact the
appropriate Regional Director or the Director.
Sec. 600.517 Allocations.
The Secretary of State, in cooperation with the Secretary,
determines the allocation among foreign nations of fish species and
species groups. The Secretary of State officially notifies each foreign
nation of its allocation. The burden of ascertaining and accurately
transmitting current allocations and status of harvest of an applicable
allocation to fishing vessels is upon the foreign nation and the owner
or operator of the FFV.
Sec. 600.518 Fee schedule for foreign fishing.
(a) Permit application fees. Each vessel permit application
submitted under Sec. 600.501 must be accompanied by a fee of $354 per
vessel, plus the surcharge, if required under paragraph (d) of this
section, rounded to the nearest dollar. At the time the application is
submitted to the DOS, a check for the fees, drawn on a U.S. bank, made
out to ``Department of Commerce, NOAA,'' must be sent to the Director.
The permit fee payment must be accompanied by a list of the vessels for
which the payment is made.
(b) Poundage fees--(1) Rates. If a Nation chooses to accept an
allocation, poundage fees must be paid at the rate specified in the
following table, plus the surcharge required by paragraph (c) of this
section.
Table--Species and Poundage Fees
[Dollars per metric ton, unless otherwise noted]
------------------------------------------------------------------------
Poundage
Species fees
------------------------------------------------------------------------
Northwest Atlantic Ocean fisheries:
1. Butterfish............................................. $274.61
2. Hake, red.............................................. 163.97
3. Hake, silver........................................... 174.63
4. Herring................................................ 61.76
5. Mackerel, Atlantic..................................... 58.33
6. Other groundfish....................................... 119.09
7. Squid, Illex........................................... 103.98
8. Squid, Loligo.......................................... 245.73
------------------------------------------------------------------------
(2) Method of payment of poundage fees, surcharges and observer
fees. (i) If a Nation chooses to accept an allocation, a revolving
letter of credit (L/C) must be established and maintained to cover the
poundage fees for at least 25 percent of the previous year's total
allocations at the rate in paragraph (b)(1) of this section, or as
determined by the
[[Page 19421]]
Assistant Administrator, plus the surcharges and observer fees required
by paragraphs (c) and (d) of this section. The L/C must--
(A) Be irrevocable;
(B) Be with a bank subscribing to ICC Pub. 290;
(C) Designate ``Department of Commerce, NOAA'' as beneficiary;
(D) Allow partial withdrawals; and
(E) Be confirmed by a U.S. bank.
(ii) The customer must pay all commissions, transmission, and
service charges. No fishing will be allowed until the L/C is
established, and authorized written notice of its issuance is provided
to the Assistant Administrator.
(3) Assessment of poundage fees. Poundage fees will be assessed
quarterly for the actual catch during January through March, April
through June, July through September, and October through December. The
appropriate Regional Director will reconcile catch figures with each
country following the procedures of Sec. 600.511(d). When the catch
figures are agreed upon, NOAA will present a bill for collection as the
documentary demand for payment to the confirming bank. If, after 45
days from the end of the quarter, catches have not been reconciled, the
estimate of the Regional Director will stand and a bill will be issued
for that amount. If necessary, the catch figures may be refined by the
Regional Director during the next 60 days, and any modifications will
be reflected in the next quarter's bill.
(c) Surcharges. The owner or operator of each foreign vessel who
accepts and pays permit application or poundage fees under paragraph
(a) or (b) of this section must also pay a surcharge. The Assistant
Administrator may reduce or waive the surcharge if it is determined
that the Fishing Vessel and Gear Damage Compensation Fund is
capitalized sufficiently. The Assistant Administrator also may increase
the surcharge during the year to a maximum level of 20 percent, if
needed, to maintain capitalization of the fund. The Assistant
Administrator has effectively waived the surcharge until further
notice.
(d) Observer fees. The Assistant Administrator will notify the
owners or operators of FFV's of the estimated annual costs of placing
observers aboard their vessels. The owners or operators of any such
vessel must provide for repayment of those costs by including one-
fourth of the estimated annual observer fee as determined by the
Assistant Administrator in a L/C as prescribed in Sec. 600.518(b)(2).
During the fiscal year, payment will be withdrawn from the L/C as
required to cover anticipated observer coverage for the upcoming
fishery. The Assistant Administrator will reconcile any differences
between the estimated cost and actual costs of observer coverage within
90 days after the end of the fiscal year.
(e) Financial assurances. (1) A foreign nation, or the owners and
operators of certain vessels of that foreign nation, may be required by
the Assistant Administrator to provide financial assurances. Such
assurances may be required if--
(i) Civil and criminal penalties assessed against fishing vessels
of the Nation have not effectively deterred violations;
(ii) Vessels of that Nation have engaged in fishing in the EEZ
without proper authorization to conduct such activities;
(iii) The Nation's vessel owners have refused to answer
administrative charges or summons to appear in court; or
(iv) Enforcement of Magnuson Act civil or criminal judgments in the
courts of a foreign nation is unattainable.
(2) The level of financial assurances will be guided by the level
of penalties assessed and costs to the U.S. Government.
Sec. 600.520 Northwest Atlantic Ocean fishery.
(a) Purpose. Sections 600.520 and 600.525 regulate all foreign
fishing conducted under a GIFA within the EEZ in the Atlantic Ocean
north of 35 deg.00' N. lat.
(b) Authorized fishery--(1) Allocations. Foreign vessels may engage
in fishing only in accordance with applicable national allocations.
(2) Time and area restrictions. (i) Fishing, including processing,
scouting, and support of foreign or U.S. vessels, is prohibited south
of 35 deg.00' N. lat., and north and east of a line beginning at the
shore at 44 deg.22' N. lat., 67 deg.52' W. long. and intersecting the
boundary of the EEZ at 44 deg.11'12'' N. lat., 67 deg.16'46'' W. long.
(ii) The Regional Director will consult with the Council prior to
giving notice of any area or time restriction. NMFS will also consult
with the USCG if the restriction is proposed to reduce gear conflicts.
If NMFS determines after such consultation that the restriction appears
to be appropriate, NMFS will publish the proposed restriction in the
Federal Register, together with a summary of the information on which
the restriction is based. Following a 30-day comment period, NMFS will
publish a final action.
(iii) The Regional Director may rescind any restriction if he/she
determines that the basis for the restriction no longer exists.
(iv) Any notice of restriction shall operate as a condition imposed
on the permit issued to the foreign vessels involved in the fishery.
(3) TALFF. The TALFFs for the fisheries of the Northwest Atlantic
Ocean are published in the Federal Register. Current TALFFs are also
available from the Regional Director.
(4) Species definitions. The category ``other finfish'' used in
TALFFs and in allocations includes all species except:
(i) The other allocated species, namely: Short-finned squid, long-
finned squid, Atlantic herring, Atlantic mackerel, river herring
(includes alewife, blueback herring, and hickory shad), and butterfish;
and
(ii) The prohibited species, namely: American plaice, American
shad, Atlantic cod, Atlantic menhaden, Atlantic redfish, Atlantic
salmon, all marlin, all spearfish, sailfish, swordfish, black sea bass,
bluefish, croaker, haddock, ocean pout, pollock, red hake, scup, sea
turtles, sharks (except dogfish), silver hake, spot, striped bass,
summer flounder, tilefish, yellowtail flounder, weakfish, white hake,
windowpane flounder, winter flounder, witch flounder, Continental Shelf
fishery resources, and other invertebrates (except nonallocated
squids).
(5) Closures. The taking of any species for which a Nation has an
allocation is permitted, provided that:
(i) The vessels of the foreign nation have not caught the
allocation of that Nation for any species or species group (e.g.,
``other finfish''). When vessels of a foreign nation have caught an
applicable allocation of any species, all further fishing other than
scouting, processing, or support by vessels of that Nation must cease,
even if other allocations have not been reached. Therefore, it is
essential that foreign nations plan their fishing strategy to ensure
that the reaching of an allocation for one species does not result in
the premature closing of a Nation's fishery for other allocated
species.
(ii) The fishery has not been closed for other reasons under
Sec. 600.521.
(6) Allocation utilization. Foreign fishing vessels may elect to
retain or discard allocated species; however, the computation of
allocation utilization and fee refunds will be based on the total
quantity of that species that was caught. Prohibited species must
always be returned to the sea as required under Sec. 600.509.
[[Page 19422]]
(c) Fishing areas. For the purposes of the Northwest Atlantic Ocean
fishery, fishing areas are that portion of the EEZ shown inside the
boundaries of the ``three digit statistical areas'' described in Figure
1 of this part.
Sec. 600.525 Atlantic herring fishery.
(a) Initial specifications. The initial specifications of OY, DAH,
DAP, JVP, TALFF, and reserve (if any) have been established by the PMP
for Atlantic herring approved on July 6, 1995. These annual
specifications will remain in effect unless adjusted pursuant to the
provisions specified in paragraph (b) of this section.
(b) Procedures to adjust initial specifications. NMFS may adjust
these initial specifications upward or downward to produce the greatest
overall benefit to the United States at any time prior to or during the
fishing years for which the initial specifications are set by
publishing notification in the Federal Register with the reasons for
such adjustments. Any notice of adjustment may provide for public
comment. Adjustments to the initial specifications may take into
account the following information:
(1) The estimated domestic processing capacity and extent to which
it will be used;
(2) Landings and catch statistics;
(3) Stock assessments; and
(4) Relevant scientific information.
Subpart G--Preemption of State Authority Under Section 306(b)
Sec. 600.605 General policy.
It is the policy of the Secretary that preemption proceedings will
be conducted expeditiously. The administrative law judge and counsel or
other representative for each party are encouraged to make every effort
at each stage of the proceedings to avoid delay.
Sec. 600.610 Factual findings for Federal preemption.
(a) The two factual findings for Federal preemption of state
management authority over a fishery are:
(1) The fishing in a fishery that is covered by an FMP implemented
under the Magnuson Act is engaged in predominately within the EEZ and
beyond such zone; and
(2) A state has taken any action, or omitted to take any action,
the results of which will substantially and adversely affect the
carrying out of such FMP.
(b) Whether fishing is engaged in ``predominately'' within or
beyond the EEZ will be determined after consideration of relevant
factors, including but not limited to, the catch (based on numbers,
value, or weight of fish caught, or other relevant factors) or fishing
effort during the appropriate period, and in light of historical
patterns of the distribution of catch or fishing effort for such stock
or stocks of fish.
(c) Whether relevant effects are substantial will be determined
after consideration of the magnitude of such actual or potential
effects. Relevant to this determination are various factors, including
but not limited to, the proportion of the fishery (stock or stocks of
fish and fishing for such stocks) that is subject to the effects of a
particular state's action or omission, the characteristics and status
(including migratory patterns and biological condition) of the stock or
stocks of fish in the fishery, and the similarity or dissimilarity
between the goals, objectives, or policies of the state's action or
omission and the management goals or objectives specified in the FMP
for the fishery or between the state and Federal conservation and
management measures of the fishery.
Sec. 600.615 Commencement of proceedings.
(a) Notice of proposed preemption. (1) If a proceeding under this
part is deemed necessary, the Administrator must issue a notice of
proposed preemption to the Attorney General of the State or States
concerned. The notice will contain:
(i) A recital of the legal authority and jurisdiction for
instituting the proceeding;
(ii) A concise statement of the Sec. 600.610 factual findings for
Federal preemption upon which the notice is based; and,
(iii) The time, place, and date of the hearing.
(2) The notice of proposed preemption will also be published in the
Federal Register. This notification may be combined with any notice of
proposed rulemaking published under paragraph (d)(1) of this section.
(b) Response. The state will have the opportunity to respond in
writing to the notice of proposed preemption.
(c) Amendment. The Administrator may, at any time prior to the
Secretary's decision, withdraw the notice of proposed preemption. Upon
motion of either party before the record is closed, the administrative
law judge may amend the notice of proposed preemption.
(d) Proposed regulations--(1) In general. If additional regulations
are required to govern fishing within the boundaries of a state, the
Administrator may publish proposed regulations in the Federal Register
concurrently with issuing the notification indicated in paragraph (a)
of this section.
(2) Emergency actions. Nothing in this section will prevent the
Secretary from taking emergency action under section 305(e) of the
Magnuson Act.
Sec. 600.620 Rules pertaining to the hearing.
(a) The civil procedure rules of the NOAA currently set forth in 15
CFR part 904, subpart C (or as subsequently amended), apply to the
proceeding after its commencement by service of notice (pursuant to
Sec. 600.615) and prior to the Secretary's decision (Sec. 600.625),
except that the following sections will not apply:
(1) 15 CFR 904.201 (Definitions);
(2) 15 CFR 904.206(a)(1) (Duties and powers of Judge); and
(3) 15 CFR 904.272 (Administrative review of decision).
(b) Additional duties and powers of judge--(1) Time periods. The
administrative law judge is authorized to modify all time periods
pertaining to the course of the hearing (under Secs. 600.615 and
600.620) to expedite the proceedings, upon application and appropriate
showing of need or emergency circumstances by a party.
(2) Intervention. Intervention by persons not parties is not
allowed.
Sec. 600.625 Secretary's decision.
(a) The Secretary will, on the basis of the hearing, record the
administrative law judge's recommended decision:
(1) Accept or reject any of the findings or conclusions of the
administrative law judge and decide whether the factual findings exist
for Federal preemption of a state's authority within its boundaries
(other than in its internal waters) with respect to the fishery in
question;
(2) Reserve decision on the merits or withdraw the notice of
proposed preemption; or
(3) Remand the case to the administrative law judge for further
proceedings as may be appropriate, along with a statement of reasons
for the remand.
(b) Notification. (1) If the factual findings for Federal
preemption are determined to exist, the Secretary will notify in
writing the Attorney General of that state and the appropriate
Council(s) of the preemption of that state's authority. The Secretary
will also direct the Administrator to promulgate appropriate
regulations proposed under Sec. 600.615(d) and otherwise to begin
regulating the fishery within the state's boundaries (other than in its
internal waters).
(2) If the factual findings for Federal preemption are determined
not to exist, the Secretary will notify, in writing, the Attorney
General of the state and the appropriate Council(s) of that
[[Page 19423]]
determination. The Secretary will also direct the Administrator to
issue a notice withdrawing any regulations proposed under
Sec. 600.615(d).
Sec. 600.630 Application for reinstatement of state authority.
(a) Application or notice. (1) At any time after the promulgation
of regulations under Sec. 600.625(b)(1) to regulate a fishery within a
state's boundaries, the affected state may apply to the Secretary for
reinstatement of state authority. The Secretary may also serve upon
such state a notice of intent to terminate such Federal regulation. A
state's application must include a clear and concise statement of:
(i) The action taken by the State to correct the action or omission
found to have substantially and adversely affected the carrying out of
the FMP; or
(ii) Any changed circumstances that affect the relationship of the
state's action or omission to take action to the carrying out of the
FMP (including any amendment to such plan); and
(iii) Any laws, regulations, or other materials that the state
believes support the application.
(2) Any such application received by the Secretary or notice issued
to the State will be published in the Federal Register.
(b) Informal response. The Secretary has sole discretion to accept
or reject the application or response. If the Secretary accepts the
application or rejects any responses and finds that the reasons for
regulation of the fishery within the boundaries of the state no longer
prevail, the Secretary will promptly terminate such regulation and
publish in the Federal Register any regulatory amendments necessary to
accomplish that end.
(c) Hearing. The Secretary has sole discretion to direct the
Administrator to schedule hearings for the receipt of evidence by an
administrative law judge. Hearings before the administrative law judge
to receive such evidence will be conducted in accordance with
Sec. 600.620. Upon conclusion of such hearings, the administrative law
judge will certify the record and a recommended decision to the
Secretary. If the Secretary, upon consideration of the state's
application or any response to the notice published under
Sec. 600.630(a)(2), the hearing record, the recommended decision, and
any other relevant materials finds that the reasons for regulation of
the fishery within the boundaries of the state no longer prevail, the
Secretary will promptly terminate such regulation and publish in the
Federal Register any regulatory amendments necessary to accomplish that
end.
Subpart H--General Provisions for Domestic Fisheries
Sec. 600.705 Relation to other laws.
(a) General. Persons affected by these regulations should be aware
that other Federal and state statutes and regulations may apply to
their activities. Vessel operators may wish to refer to USCG
regulations found in the Code of Federal Regulations title 33--
Navigation and Navigable Waters and 46--Shipping; 15 CFR part 904,
subpart D--Permit Sanctions and Denials; and title 43--Public Lands (in
regard to marine sanctuaries).
(b) State responsibilities. Certain responsibilities relating to
data collection and enforcement may be performed by authorized state
personnel under a state/Federal agreement for data collection and a
tripartite agreement among the state, the USCG, and the Secretary for
enforcement.
(c) Submarine cables. Fishing vessel operators must exercise due
care in the conduct of fishing activities near submarine cables. Damage
to the submarine cables resulting from intentional acts or from the
failure to exercise due care in the conduct of fishing operations
subjects the fishing vessel operator to the criminal penalties
prescribed by the Submarine Cable Act (47 U.S.C. 21) which implements
the International Convention for the Protection of Submarine Cables.
Fishing vessel operators also should be aware that the Submarine Cable
Act prohibits fishing operations at a distance of less than 1 nautical
mile (1.85 km) from a vessel engaged in laying or repairing a submarine
cable; or at a distance of less than 0.25 nautical mile (0.46 km) from
a buoy or buoys intended to mark the position of a cable when being
laid or when out of order or broken.
(d) Marine mammals. Regulations governing exemption permits and the
recordkeeping and reporting of the incidental take of marine mammals
are set forth in part 229 of this title.
(e) Halibut fishing. Fishing for halibut is governed by regulations
of the International Pacific Halibut Commission set forth at part 300
of this title.
(f) Marine sanctuaries. All fishing activity, regardless of species
sought, is prohibited under 15 CFR part 924 in the U.S.S. Monitor
Marine Sanctuary, which is located approximately 15 miles southwest of
Cape Hatteras off the coast of North Carolina.
Sec. 600.710 Permits.
Regulations pertaining to permits required for certain fisheries
are set forth in the parts of this chapter governing those fisheries.
Sec. 600.715 Recordkeeping and reporting.
Regulations pertaining to records and reports required for certain
fisheries are set forth in the parts of this chapter governing those
fisheries.
Sec. 600.720 Vessel and gear identification.
Regulations pertaining to special vessel and gear markings required
for certain fisheries are set forth in the parts of this chapter
governing those fisheries.
Sec. 600.725 General prohibitions.
It is unlawful for any person to do any of the following:
(a) Possess, have custody or control of, ship, transport, offer for
sale, sell, purchase, land, import, or export, any fish or parts
thereof taken or retained in violation of the Magnuson Act or any
regulation or permit issued under the Magnuson Act.
(b) Transfer or attempt to transfer, directly or indirectly, any
U.S.-harvested fish to any foreign fishing vessel, while such vessel is
in the EEZ, unless the foreign fishing vessel has been issued a permit
under section 204 of the Magnuson Act, which authorizes the receipt by
such vessel of U.S.- harvested fish.
(c) Fail to comply immediately with enforcement and boarding
procedures specified in Sec. 600.730.
(d) Refuse to allow an authorized officer to board a fishing vessel
or to enter areas of custody for purposes of conducting any search,
inspection, or seizure in connection with the enforcement of the
Magnuson Act.
(e) Dispose of fish or parts thereof or other matter in any manner,
after any communication or signal from an authorized officer, or after
the approach by an authorized officer or an enforcement vessel or
aircraft.
(f) Assault, resist, oppose, impede, intimidate, threaten, or
interfere with any authorized officer in the conduct of any search,
inspection, or seizure in connection with enforcement of the Magnuson
Act.
(g) Interfere with, delay, or prevent by any means, the
apprehension of another person, knowing that such person has committed
any act prohibited by the Magnuson Act.
(h) Resist a lawful arrest for any act prohibited under the
Magnuson Act.
(i) Make any false statement, oral or written, to an authorized
officer concerning the taking, catching, harvesting, landing, purchase,
sale, offer
[[Page 19424]]
of sale, possession, transport, import, export, or transfer of any
fish, or attempts to do any of the above.
(j) Interfere with, obstruct, delay, or prevent by any means an
investigation, search, seizure, or disposition of seized property in
connection with enforcement of the Magnuson Act.
(k) Fish in violation of the terms or conditions of any permit or
authorization issued under the Magnuson Act.
(l) Fail to report catches as required while fishing pursuant to an
exempted fishing permit.
(m) On a scientific research vessel, engage in fishing other than
recreational fishing authorized by applicable state or Federal
regulations.
(n) Trade, barter, or sell; or attempt to trade, barter, or sell
fish possessed or retained while fishing pursuant to an authorization
for an exempted educational activity.
(o) Harass or sexually harass an authorized officer or an observer.
Sec. 600.730 Facilitation of enforcement.
(a) General. The operator of, or any other person aboard, any
fishing vessel subject to parts 625 through 699 of this chapter must
immediately comply with instructions and signals issued by an
authorized officer to stop the vessel and with instructions to
facilitate safe boarding and inspection of the vessel, its gear,
equipment, fishing record (where applicable), and catch for purposes of
enforcing the Magnuson Act and this chapter.
(b) Communications. (1) Upon being approached by a USCG vessel or
aircraft, or other vessel or aircraft with an authorized officer
aboard, the operator of a fishing vessel must be alert for
communications conveying enforcement instructions.
(2) VHF-FM radiotelephone is the preferred method for communicating
between vessels. If the size of the vessel and the wind, sea, and
visibility conditions allow, a loudhailer may be used instead of the
radio. Hand signals, placards, high frequency radiotelephone, or voice
may be employed by an authorized officer, and message blocks may be
dropped from an aircraft.
(3) If other communications are not practicable, visual signals may
be transmitted by flashing light directed at the vessel signaled. USCG
units will normally use the flashing light signal ``L'' as the signal
to stop. In the International Code of Signals, ``L'' (.-..) means ``you
should stop your vessel instantly.'' (Period (.) means a short flash of
light; dash (-) means a long flash of light.)
(4) Failure of a vessel's operator promptly to stop the vessel when
directed to do so by an authorized officer using loudhailer,
radiotelephone, flashing light signal, or other means constitutes prima
facie evidence of the offense of refusal to permit an authorized
officer to board.
(5) The operator of a vessel who does not understand a signal from
an enforcement unit and who is unable to obtain clarification by
loudhailer or radiotelephone must consider the signal to be a command
to stop the vessel instantly.
(c) Boarding. The operator of a vessel directed to stop must:
(1) Guard Channel 16, VHF-FM, if so equipped;
(2) Stop immediately and lay to or maneuver in such a way as to
allow the authorized officer and his/her party to come aboard;
(3) Except for those vessels with a freeboard of 4 ft (1.2 m) or
less, provide a safe ladder, if needed, for the authorized officer and
his/her party to come aboard;
(4) When necessary to facilitate the boarding or when requested by
an authorized officer or observer, provide a manrope or safety line,
and illumination for the ladder; and
(5) Take such other actions as necessary to facilitate boarding and
to ensure the safety of the authorized officer and the boarding party.
(d) Signals. The following signals, extracted from the
International Code of Signals, may be sent by flashing light by an
enforcement unit when conditions do not allow communications by
loudhailer or radiotelephone. Knowledge of these signals by vessel
operators is not required. However, knowledge of these signals and
appropriate action by a vessel operator may preclude the necessity of
sending the signal ``L'' and the necessity for the vessel to stop
instantly. (Period (.) means a short flash of light; dash (-) means a
long flash of light.)
(1) ``AA'' repeated (.-.-) is the call to an unknown station. The
operator of the signaled vessel should respond by identifying the
vessel by radiotelephone or by illuminating the vessel's
identification.
(2) ``RY-CY'' (.-. -.-- -.-. -.--) means ``you should proceed at
slow speed, a boat is coming to you.'' This signal is normally employed
when conditions allow an enforcement boarding without the necessity of
the vessel being boarded coming to a complete stop, or, in some cases,
without retrieval of fishing gear which may be in the water.
(3) ``SQ3'' (... --.- ...--) means ``you should stop or heave to; I
am going to board you.''
Sec. 600.735 Penalties.
Any person committing, or fishing vessel used in the commission of
a violation of the Magnuson Act or any regulation issued under the
Magnuson Act, is subject to the civil and criminal penalty provisions
and civil forfeiture provisions of the Magnuson Act, to this section,
to 15 CFR part 904 (Civil Procedures), and to other applicable law.
Sec. 600.740 Enforcement policy.
(a) The Magnuson Act provides four basic enforcement remedies for
violations, in ascending order of severity, as follows:
(1) Issuance of a citation (a type of warning), usually at the
scene of the offense (see 15 CFR part 904, subpart E);
(2) Assessment by the Administrator of a civil money penalty;
(3) For certain violations, judicial forfeiture action against the
vessel and its catch; and
(4) Criminal prosecution of the owner or operator for some
offenses. It shall be the policy of NMFS to enforce vigorously and
equitably the provisions of the Magnuson Act by utilizing that form or
combination of authorized remedies best suited in a particular case to
this end.
(b) Processing a case under one remedial form usually means that
other remedies are inappropriate in that case. However, further
investigation or later review may indicate the case to be either more
or less serious than initially considered, or may otherwise reveal that
the penalty first pursued is inadequate to serve the purposes of the
Magnuson Act. Under such circumstances, the Agency may pursue other
remedies either in lieu of or in addition to the action originally
taken. Forfeiture of the illegal catch does not fall within this
general rule and is considered in most cases as only the initial step
in remedying a violation by removing the ill-gotten gains of the
offense.
(c) If a fishing vessel for which a permit has been issued under
the Magnuson Act is used in the commission of an offense prohibited by
section 307 of the Magnuson Act, NOAA may impose permit sanctions,
whether or not civil or criminal action has been undertaken against the
vessel or its owner or operator. In some cases, the Magnuson Act
requires permit sanctions following the assessment of a civil penalty
or the imposition of a criminal fine. In sum, the Magnuson Act treats
sanctions against the fishing
[[Page 19425]]
vessel permit to be the carrying out of a purpose separate from that
accomplished by civil and criminal penalties against the vessel or its
owner or operator.
Sec. 600.745 Scientific research activity, exempted fishing, and
exempted educational activity.
(a) Scientific research activity. Nothing in this section is
intended to inhibit or prevent any scientific research activity
conducted by a scientific research vessel. Persons planning to conduct
scientific research activities in the EEZ are encouraged to submit to
the appropriate Regional Director, Director, or designee, 60 days or as
soon as practicable prior to its start, a scientific research plan for
each scientific cruise. The Regional Director, Director, or designee
will acknowledge notification of scientific research activity by
issuing to the operator or master of that vessel, or to the sponsoring
institution, a letter of acknowledgment. This letter of acknowledgment
is separate and distinct from any permit required by any other
applicable law. If the Regional Director, Director, or designee, after
review of a research plan, determines that it does not constitute
scientific research but rather fishing, the Regional Director,
Director, or designee will inform the applicant as soon as practicable
and in writing. The Regional Director, Director, or designee may also
make recommendations to revise the research plan to make the cruise
acceptable as scientific research activity or recommend the applicant
request an EFP. In order to facilitate identification of activity as
scientific research, persons conducting scientific research activities
are advised to carry a copy of the scientific research plan and the
letter of acknowledgment on board the scientific research vessel.
Activities conducted in accordance with a scientific research plan
acknowledged by such a letter are presumed to be scientific research
activity. The presumption may be overcome by showing that an activity
does not fit the definition of scientific research activity or is
outside the scope of the scientific research plan.
(b) Exempted fishing--(1) General. A NMFS Regional Director or
Director may authorize, for limited testing, public display, data
collection, and/or exploratory purposes, the target or incidental
harvest of species managed under an FMP or fishery regulations that
would otherwise be prohibited. Exempted fishing may not be conducted
unless authorized by an EFP issued by a Regional Director or Director
in accordance with the criteria and procedures specified in this
section. The Regional Director or Director may charge a fee to recover
the administrative expenses of issuing an EFP. The amount of the fee
will be calculated, at least annually, in accordance with procedures of
the NOAA Handbook (available from the Director or Regional Directors)
for determining administrative costs of each special product or
service; the fee may not exceed such costs. Persons may contact the
appropriate Regional Director or Director to find out the applicable
fee.
(2) Application. An applicant for an EFP shall submit a completed
application package to the appropriate Regional Director or Director,
as soon as practicable and at least 60 days before the desired
effective date of the EFP. Submission of an EFP application less than
60 days before the desired effective date of the EFP may result in a
delayed effective date because of review requirements. The application
package must include payment of any required fee as specified by
paragraph (b)(1) of this section, and a written application that
includes, but is not limited to, the following information:
(i) The date of the application;
(ii) The applicant's name, mailing address, and telephone number;
(iii) A statement of the purposes and goals of the exempted fishery
for which an EFP is needed, including justification for issuance of the
EFP;
(iv) For each vessel to be covered by the EFP, as soon as the
information is available and before operations begin under the EFP:
(A) A copy of the USCG documentation, state license, or
registration of each vessel, or the information contained on the
appropriate document; and
(B) The current name, address, and telephone number of the owner
and master, if not included on the document provided for the vessel;
(v) The species (target and incidental) expected to be harvested
under the EFP, the amount(s) of such harvest necessary to conduct the
exempted fishing, the arrangements for disposition of all regulated
species harvested under the EFP, and any anticipated impacts on marine
mammals or endangered species;
(vi) For each vessel covered by the EFP, the approximate time(s)
and place(s) fishing will take place, and the type, size, and amount of
gear to be used; and
(vii) The signature of the applicant.
(viii) The Regional Director or Director, as appropriate, may
request from an applicant additional information necessary to make the
determinations required under this section. An incomplete application
or an application for which the appropriate fee has not been paid will
not be considered until corrected in writing and the fee paid. An
applicant for an EFP need not be the owner or operator of the vessel(s)
for which the EFP is requested.
(3) Issuance. (i) The Regional Director or Director, as
appropriate, will review each application and will make a preliminary
determination whether the application contains all of the required
information and constitutes an activity appropriate for further
consideration. If the Regional Director or Director finds that any
application does not warrant further consideration, both the applicant
and the affected Council(s) will be notified in writing of the reasons
for the decision. If the Regional Director or Director determines that
any application warrants further consideration, notification of receipt
of the application will be published in the Federal Register with a
brief description of the proposal, and the intent of NMFS to issue an
EFP. Interested persons will be given a 15- to 45-day opportunity to
comment. The notification may establish a cut-off date for receipt of
additional applications to participate in the same, or a similar,
exempted fishing activity. The Regional Director or Director also will
forward copies of the application to the Council(s), the USCG, and the
appropriate fishery management agencies of affected states, accompanied
by the following information:
(A) The effect of the proposed EFP on the target and incidental
species, including the effect on any TAC;
(B) A citation of the regulation or regulations that, without the
EFP, would prohibit the proposed activity; and
(C) Biological information relevant to the proposal, including
appropriate statements of environmental impacts, including impacts on
marine mammals and threatened or endangered species.
(ii) If the application is complete and warrants additional
consultation, the Regional Director or Director may consult with the
appropriate Council(s) concerning the permit application during the
period in which comments have been requested. The Council(s) or the
Director or Regional Director shall notify the applicant in advance of
any meeting at which the application will be considered, and offer the
applicant the opportunity to appear in support of the application.
(iii) As soon as practicable after receiving responses from the
agencies identified above, and/or after the consultation, if any,
described in paragraph (b)(3)(ii) of this section, the Regional
Director or Director shall
[[Page 19426]]
notify the applicant in writing of the decision to grant or deny the
EFP, and, if denied, the reasons for the denial. Grounds for denial of
an EFP include, but are not limited to, the following:
(A) The applicant has failed to disclose material information
required, or has made false statements as to any material fact, in
connection with his or her application; or
(B) According to the best scientific information available, the
harvest to be conducted under the permit would detrimentally affect the
well-being of the stock of any regulated species of fish, marine
mammal, or threatened or endangered species in a significant way; or
(C) Issuance of the EFP would have economic allocation as its sole
purpose; or
(D) Activities to be conducted under the EFP would be inconsistent
with the intent of this section, the management objectives of the FMP,
or other applicable law; or
(E) The applicant has failed to demonstrate a valid justification
for the permit; or
(F) The activity proposed under the EFP could create a significant
enforcement problem.
(iv) The decision of a Regional Director or Director to grant or
deny an EFP is the final action of NMFS. If the permit, as granted, is
significantly different from the original application, or is denied,
NMFS may publish notification in the Federal Register describing the
exempted fishing to be conducted under the EFP or the reasons for
denial.
(v) Terms and conditions of EFPs. The Regional Director or Director
may attach terms and conditions to the EFP consistent with the purpose
of the exempted fishing, including, but not limited to:
(A) The maximum amount of each regulated species that can be
harvested and landed during the term of the EFP, including trip
limitations, where appropriate;
(B) The number, size(s), name(s), and identification number(s) of
the vessel(s) authorized to conduct fishing activities under the EFP;
(C) The time(s) and place(s) where exempted fishing may be
conducted;
(D) The type, size, and amount of gear that may be used by each
vessel operated under the EFP;
(E) The condition that observers, a vessel monitoring system, or
other electronic equipment be carried on board vessels operated under
an EFP, and any necessary conditions, such as predeployment
notification requirements;
(F) Reasonable data reporting requirements;
(G) Other conditions as may be necessary to assure compliance with
the purposes of the EFP, consistent with the objectives of the FMP and
other applicable law; and
(H) Provisions for public release of data obtained under the EFP
that are consistent with NOAA confidentiality of statistics procedures
at set out in subpart E. An applicant may be required to waive the
right to confidentiality of information gathered while conducting
exempted fishing as a condition of an EFP.
(4) Duration. Unless otherwise specified in the EFP or a
superseding notice or regulation, an EFP is effective for no longer
than 1 year, unless revoked, suspended, or modified. EFPs may be
renewed following the application procedures in this section.
(5) Alteration. Any permit that has been altered, erased, or
mutilated is invalid.
(6) Transfer. EFPs issued under this section are not transferable
or assignable. An EFP is valid only for the vessel(s) for which it is
issued.
(7) Inspection. Any EFP issued under this section must be carried
on board the vessel(s) for which it was issued. The EFP must be
presented for inspection upon request of any authorized officer.
(8) Sanctions. Failure of a permittee to comply with the terms and
conditions of an EFP may be grounds for revocation, suspension, or
modification of the EFP with respect to all persons and vessels
conducting activities under the EFP. Any action taken to revoke,
suspend, or modify an EFP for enforcement purposes will be governed by
15 CFR part 904, subpart D.
(c) Reports. (1) Persons conducting scientific research activity
are requested to submit a copy of any cruise report or other
publication created as a result of the cruise, including the amount,
composition, and disposition of their catch, to the appropriate Science
and Research Director.
(2) Persons fishing under an EFP are required to report their
catches to the appropriate Regional Director or Director, as specified
in the EFP.
(d) Exempted educational activities--(1) General. A NMFS Regional
Director or Director may authorize, for educational purposes, the
target or incidental harvest of species managed under an FMP or fishery
regulations that would otherwise be prohibited. The decision of a
Regional Director or Director to grant or deny an exempted educational
activity authorization is the final action of NMFS. Exempted
educational activities may not be conducted unless authorized in
writing by a Regional Director or Director in accordance with the
criteria and procedures specified in this section. Such authorization
will be issued without charge.
(2) Application. An applicant for an exempted educational activity
authorization shall submit to the appropriate Regional Director or
Director, at least 15 days before the desired effective date of the
authorization, a written application that includes, but is not limited
to, the following information:
(i) The date of the application;
(ii) The applicant's name, mailing address, and telephone number;
(iii) A brief statement of the purposes and goals of the exempted
educational activity for which authorization is requested, including a
general description of the arrangements for disposition of all species
collected;
(iv) Evidence that the sponsoring institution is a valid
educational institution, such as accreditation by a recognized national
or international accreditation body;
(v) The scope and duration of the activity;
(vi) For each vessel to be covered by the authorization:
(A) A copy of the U.S. Coast Guard documentation, state license, or
registration of the vessel, or the information contained on the
appropriate document;
(B) The current name, address, and telephone number of the owner
and master, if not included on the document provided for the vessel;
(vii) The species and amounts expected to be caught during the
exempted educational activity;
(viii) For each vessel covered by the authorization, the
approximate time(s) and place(s) fishing will take place, and the type,
size, and amount of gear to be used; and
(ix) The signature of the applicant.
(x) The Regional Director or Director may request from an applicant
additional information necessary to make the determinations required
under this section. An incomplete application will not be considered
until corrected in writing.
(3) Issuance. (i) The Regional Director or Director, as
appropriate, will review each application and will make a determination
whether the application contains all of the required information, is
consistent with the goals, objectives, and requirements of the FMP or
regulations and other applicable law, and constitutes a valid exempted
educational activity. The applicant will
[[Page 19427]]
be notified in writing of the decision within 5 working days of receipt
of the application.
(ii) The Regional Director or Director may attach terms and
conditions to the authorization, consistent with the purpose of the
exempted educational activity, including, but not limited to:
(A) The maximum amount of each regulated species that may be
harvested;
(B) The time(s) and place(s) where the exempted educational
activity may be conducted;
(C) The type, size, and amount of gear that may be used by each
vessel operated under the authorization;
(D) Reasonable data reporting requirements;
(E) Such other conditions as may be necessary to assure compliance
with the purposes of the authorization, consistent with the objectives
of the FMP or regulations; and
(F) Provisions for public release of data obtained under the
authorization, consistent with NOAA confidentiality of statistics
procedures in subpart E. An applicant may be required to waive the
right to confidentiality of information gathered while conducting
experimental fishing as a condition of an EFP.
(iii) The authorization will specify the scope of the authorized
activity and will include, at a minimum, the duration, vessel(s),
species and gear involved in the activity, as well as any additional
terms and conditions specified under paragraph (d)(3)(ii) of this
section.
(4) Duration. Unless otherwise specified, authorization for an
exempted educational activity is effective for no longer than 1 year,
unless revoked, suspended, or modified. Authorizations may be renewed
following the application procedures in this section.
(5) Alteration. Any authorization that has been altered, erased, or
mutilated is invalid.
(6) Transfer. Authorizations issued under this paragraph (d) are
not transferable or assignable.
(7) Inspection. Any authorization issued under this paragraph (d)
must be carried on board the vessel(s) for which it was issued or be in
possession of the applicant to which it was issued while the exempted
educational activity is being conducted. The authorization must be
presented for inspection upon request of any authorized officer.
Activities that meet the definition of fishing, despite an educational
purpose, are fishing. An authorization may allow covered fishing
activities; however, fishing activities conducted outside the scope of
an authorization for exempted educational activities are illegal.
BILLING CODE 3510-22-P
[[Page 19428]]
Figure 1 to Part 600--Fishing Areas of the Northwest Atlantic Ocean
Fisheries
[GRAPHIC] [TIFF OMITTED] TP01MY96.000
BILLING CODE 3510-22-C
[[Page 19429]]
PARTS 601, 602, 603, 605, 611, 619, 620, AND 621--[REMOVED]
2. Under the authority of 16 U.S.C. 1801 et seq., parts 601, 602,
603, 605, 611, 619, 620, and 621 are removed.
[FR Doc. 96-9988 Filed 4-30-96; 8:45 am]
BILLING CODE 3510-22-P
Complete official Federal Register PDF
FR Doc. 96-9707 Corrective Action for Releases From Solid Waste Management Units at Hazardous Waste Management Facilities
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19432-19464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9707]
[[Page 19431]]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
40 CFR Ch. I
Corrective Action for Releases From Solid Waste Management Units at
Hazardous Waste Management Facilities; Proposed Rule
Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 /
Proposed Rules
[[Page 19432]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Ch. I
[FRL-5460-2]
RIN 2050-AB80
Corrective Action for Releases From Solid Waste Management Units
at Hazardous Waste Management Facilities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: Today's action has three purposes. First, it introduces EPA's
strategy for promulgating regulations governing corrective action for
releases from solid waste management units at hazardous waste
management facilities under the Resource Conservation and Recovery Act
(RCRA) and requests information to assist in identification and
development of potential improvements to the protectiveness,
responsiveness, speed or efficiency of corrective actions. The Agency
originally proposed corrective action regulations on July 27, 1990.
Second, to provide context for potential revisions to the corrective
action program, today's Notice includes a general status report on the
corrective action program and how it has evolved since the 1990
proposal, and provides guidance on a number of topics not fully
addressed in 1990. Third, it emphasizes areas of flexibility within the
current program and describes program improvements currently underway
or under consideration.
DATES: To ensure consideration, information and data must be received
on or before July 30, 1996.
EPA will hold a public hearing on this Notice on June 3, 1996.
ADDRESSES: Written comments responding to today's Notice should be
addressed to: Docket Clerk, U.S. Environmental Protection Agency, RCRA
Docket (OS-305), 401 M Street SW, Washington, D.C. 20460. Comments sent
by special delivery, such as overnight express services, should be
addressed to: RCRA Docket Information Center (RIC), Crystal Gateway
One, 1235 Jefferson Davis Highway, First Floor, Arlington, VA 22202.
Electronic comments should be addressed to: RCRA-
D[email protected].
The June 3, 1996 public hearing will be held at the Key Bridge
Marriott, located at 1401 Lee Highway, Arlington, VA 22209. Advance
requests to speak at the hearing should be submitted, in writing, to:
Hugh Davis (5303W) U. S. Environmental Protection Agency, 401 M Street,
SW, Washington, DC 20460.
For important additional instructions on submitting comments or
making a request to speak at the public hearing, see Supplementary
Information.
FOR FURTHER INFORMATION CONTACT: For general information, contact the
RCRA Hotline at (800) 424-9346 (toll-free) or (800) 553-7672 (hearing
impaired), or (703) 412-9810 (locally), Monday-Friday, 8:00-5:00
eastern standard time. For technical information, contact Hugh Davis,
Office of Solid Waste (5303W), U.S. Environmental Protection Agency,
401 M Street SW, Washington, D.C. 20460. Phone, (703) 308-8633. E-mail
address, [email protected].
SUPPLEMENTARY INFORMATION:
Instructions for Submitting Comments and Requests To Speak at the
Public Hearing
Commenters should place the docket number (F-96-CA2P-FFFFF) on all
comments and submit an original and two copies. Comments also may be
submitted electronically, through the Internet. Comments submitted
electronically should be in ASCI to avoid the use of special characters
and encryptions.
The official record for this action will be kept in paper form. EPA
will transfer all comments received electronically into paper form and
place them, with comments submitted directly in writing, in the
official record. EPA responses to comments will be recorded in a notice
in the Federal Register or in an official record for this action. EPA
will not immediately reply to electronic comments other than to seek
clarification of comments that may be garbled in transmission or during
conversion to paper form.
Confidential business information (CBI) may be included in
comments, however, to ensure continued confidentiality, it must be
submitted under separate cover. If including CBI, commenters should
submit an original and two copies to: U.S. Environmental Protection
Agency, RCRA CBI Document Control Officer, OSW (5303W), 401 M Street
SW, Washington, D.C. 20460. Place the docket number (F-96-CA2P-FFFFF)
on the CBI and include a reference to any non-CBI comments submitted.
Do not submit CBI electronically.
Docket materials may be reviewed by appointment by calling (703)
603-9230. The docket is located on the first floor of the Crystal
Gateway building at 1235 Jefferson Davis Highway in Arlington, Virginia
and is open from 9:00 a.m. to 4:00 p.m., Monday through Friday,
excluding Federal holidays. A maximum of 100 pages of material may be
copied at no cost from any one regulatory docket. Additional copies are
$0.15 per page. The main switchboard number for the hotel is (703) 524-
6400.
Individuals interested in directions to the June 3, 1996 public
hearing at the Key Bridge Marriott or room reservations should contact
the hotel directly at (703) 524-6400. Registration for the hearing will
begin at the hotel at 8:30 am. The hearing will begin at 9:00 am. and
end at 5:00 pm unless concluded earlier. Oral and written statements
may be submitted at the public hearing. Time for the public hearing is
limited; oral presentations will be made in the order that requests are
received and will be limited to 15 minutes, unless additional time is
available. Advance requests to speak at the public hearing should be
clearly marked as a request to speak at the public hearing and include
the scheduled date of the hearing (June 3, 1996) and the docket number
for this action (F-96-CA2P-FFFFF). Requests to speak at the public
hearing may also be made on the day of the hearing, by registering at
the door; request to speak by individuals who choose to register at the
door on the day of the hearing will be granted in the order received,
as time permits. All individuals who choose to speak at the public
hearing are requested to provide a paper copy of their testimony for
the record.
Internet Access
This notice is available on the Internet. To access today's Notice
electronically:
Gopher: gopher.epa.gov
WWW: http://www.epa.gov
Dial-up: (919) 558-0353
From the main EPA Gopher menu, select: EPA Offices and Regions/
Office of Solid Waste and Emergency Response (OSWER)/Office of Solid
Waste (RCRA)/Hazardous Waste/Corrective Action.
FTP: ftp.epa.gov
Login: anonymous
Password: your Internet address
Files are located in /pub/gopher/oswrcra
Glossary of Commonly Used Acronyms
ASTM--American Society for Testing and Materials
ASTSWMO--Association of State and Territorial Solid Waste Management
Officials
CAMU--Corrective Action Management Unit
CAP--Corrective Action Plan
CERCLA--Comprehensive Environmental Response, Compensation and
Liability Act
CMI--Corrective Measures Implementation
[[Page 19433]]
CMS--Corrective Measures Study
CSGWPP--Comprehensive State Groundwater Protection Program
DQO--Data Quality Objective
EAB--Environmental Appeals Board
FACA--Financial Assurance for Corrective Action
HSWA--Hazardous and Solid Waste Amendments
LDR--RCRA Land Disposal Restrictions
MCL--Maximum Contaminant Limit
MTR--RCRA Minimum Technology Requirements
NCAPS--National Corrective Action Prioritization System
NPL--National Priorities List
NCP--National Oil and Hazardous Substances Pollution Contingency
Plan
OSW--EPA Office of Solid Waste
OSWER--EPA Office of Solid Waste and Emergency Response
POC--Point of Compliance
RBCA--Risk Based Corrective Action (refers to ASTM standard E1739-
95)
RCRA--Resource Conservation and Recovery Act
RFA--RCRA Facility Assessment
RFI--RCRA Facility Investigation
RU--Regulated Unit
SWMU--Solid Waste Management Unit
SSG--EPA Soil Screening Guidance
TI--Technical Impracticability
TSDF--Treatment, Storage, or Disposal Facility
UST--Underground Storage Tank
Outline
I. Background
A. Statutory and Regulatory Requirements
B. Summary of Today's Notice
II. Subpart S Initiative
A. Objectives
B. Outreach
1. States
2. Environmental and Public Interest Community
3. Regulated Community
4. Other Federal Agencies
C. On-Going Role of the States
D. Strategy and Schedule
E. Major Corrective Action Program Developments Since 1990
1. Stabilization Initiative
2. Environmental Indicators for Corrective Action
3. Corrective Action Plan
4. CAMU Rule
5. Other Developments
F. Relationship to Other Agency Initiatives and Rulemakings
1. HWIR Media
2. Post-Closure Rule
a. The Post-Closure Permit Requirement
b. Applicability of 40 CFR Parts 264 and 265 to Regulated Units
Requiring Corrective Action
c. State Corrective Action Enforcement Authority
3. RCRA Statutory Reform
4. Improvements to the Procedures for Authorization of State
Hazardous Waste Program Revisions
5. Superfund Reauthorization
6. Superfund Administrative Improvements and Reforms
a. Guidance on Land Use
b. Soil Screening Guidance
c. Presumptive Remedies
d. Community Based Remedy Selection
7. Brownfields Initiative
8. Environmental Justice
9. Permits Improvement Team
III. Corrective Action Implementation
A. Program Management Philosophy
B. Scope and Definitions
1. Concept of Parity
2. Voluntary Cleanup
3. Definitions
a. Facility
b. Release
c. Solid Waste Management Unit
d. Hazardous Waste and Hazardous Constituent
C. Corrective Action Process
1. Initial Site Assessment
a. Facility Owners/Operators May Gather RFA Information
b. Release Assessment
c. National Corrective Action Prioritization System
2. Site Characterization
a. Conceptual Site Models
b. Innovative Site Characterization Technologies
c. Tailored Data Quality Objectives
d. Use of Existing Information to Streamline the Remedial
Investigation
e. Role of Action Levels
f. Integration With the Evaluation of Remedial Alternatives
3. Interim Actions
4. Evaluation of Remedial Alternatives
a. Integration With Site Characterization
b. Formal Evaluation Not Always Necessary
c. Facility Owner/Operator Should Recommend a Preferred Remedy
5. Remedy Selection
a. Balancing Treatment and Exposure Control
b. Remedy Selection Criteria
c. Media Cleanup Standards
d. Points of Compliance
e. Compliance Time Frame
f. Site-Specific Risk Assessments
g. Ecological Risk
h. Determinations of Technical Impracticability
i. Natural Attenuation
j. Land Use
6. Remedy Implementation
a. Performance Based Corrective Measures Implementation
b. Performance Monitoring
c. Completion of Corrective Measures
D. Incorporation of Corrective Action in RCRA Permits
E. Corrective Action Orders
F. Public Involvement and Environmental Justice
G. Financial Assurance
IV. Corrective Action Program Priorities
V. Request for Comment and Data
A. General
B. Resolution of the 1990 Proposal.
C. Focusing the Corrective Action Program on Results
1. Performance Standards
2. Less Focus on Solid Waste Management Units
D. Using Non-RCRA Authorities for Corrective Action
1. State Cleanup Programs
2. Enhanced Flexibility for States with EPA-Endorsed CSGWPPs
3. Voluntary Corrective Action
4. Corrective Action at Interim Status Facilities
5. Independent or Self-Implementing Corrective Action
6. Consistency With the CERCLA Program
7. ASTM RBCA Standard
8. Definition of Facility for Corrective Action
E. Balance Between Site-Specific Flexibility and National
Consistency
1. Land Use
2. Points of Compliance
3. Standardized Lists of Action Levels and Media Cleanup Levels
4. Area Wide Contamination Issues
5. Ecological Risk
6. Risk Assessment Methods
F. Public Participation and Environmental Justice
G. When Permits Can Be Terminated
H. Effect of Property Transfer on Corrective Action Requirements
I. Financial Assurance for Corrective Action
J. State Authorization
I. Background
A. Statutory and Regulatory Requirements
In the 1984 Hazardous and Solid Waste Amendments (HSWA) to the
Resource Conservation and Recovery Act (RCRA), Congress directed EPA to
require corrective action for all releases of hazardous waste and
hazardous constituents from solid waste management units at facilities
seeking RCRA permits (i.e., hazardous waste Treatment, Storage or
Disposal Facilities or TSDFs) regardless of the time at which waste was
placed in the units. When corrective action cannot be completed prior
to permit issuance, the statute directs EPA to specify corrective
action schedules of compliance and financial assurance in all permits
issued under RCRA section 3005. In addition, EPA is directed to require
that corrective action be taken beyond facility boundaries unless
facility owners/operators demonstrate to the Agency's satisfaction
that, despite their best efforts, they were unable to obtain the
necessary permission to undertake off-site corrective action. (See,
RCRA section 3004 (u) and (v), 42 U.S.C. 6924 (u) and (v).) At the same
time, Congress enacted the RCRA permit omnibus provision directing
that, ``each permit issued under [RCRA Section 3005] contain such terms
and conditions as the Administrator determines necessary to protect
human health and the environment.'' (See, RCRA sections 3005(C)(3), 42
U.S.C. 6925(c)(3).) EPA is authorized to require corrective action
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at interim status facilities under RCRA section 3008(h), 42 U.S.C.
6928(h).
At the time the new corrective action provisions were enacted,
corrective action for releases to groundwater from RCRA regulated units
was already required under 40 CFR part 264, subpart F. RCRA regulated
units are defined in 40 CFR 264.90 as surface impoundments, waste
piles, land treatment units, and landfills that received hazardous
waste after July 26, 1982; they are a subset of the universe of solid
waste management units. The 1984 HSWA amendments extended corrective
action authority at TSDFs to all waste management at units that
received solid or hazardous waste at any time. In the legislative
history of RCRA section 3004(u), Congress noted that one purpose of the
new corrective action requirements was to ensure that RCRA facilities
did not become Superfund cleanup sites. The legislative history records
that, ``Unless all hazardous constituents released from solid waste
management units at permitted facilities are addressed and cleaned up
the Committee is deeply concerned that many more sites will be added to
the future burdens of the Superfund program with little prospect for
control or cleanup. The responsibility to control such releases lies
with the facility owner and operator and should not be shifted to the
Superfund program, particularly when a final permit has been requested
by the facility.'' (See, H.R. Rep. No. 198, 98th Cong., 1st Sess., part
1, 61 (1983).)
In July 1985, EPA codified corrective action requirements at 40 CFR
264.90(a)(2); 264.101; 270.60(b) and 270.60(c). (See, 50 FR 28702, July
15, 1985.) These regulations reiterate the statutory language of RCRA
section 3004(u) by requiring facility owners/operators seeking RCRA
permits to institute corrective action, as necessary to protect human
health and the environment, for all releases of hazardous waste and
constituents from solid waste management units at the facility. When
corrective action cannot be completed prior to permitting, EPA requires
that all permits contain corrective action requirements, schedules of
compliance, and financial assurance. In 40 CFR 270.60(b) and 270.60(c),
EPA clarified that corrective action is also required for some
facilities with RCRA permits-by-rule, including hazardous waste
management facilities with permits issued under the Underground
Injection Control program and the National Pollution Discharge
Elimination System (NPDES) permitting program.
In December 1987 (52 FR 45788, December 1, 1987), EPA promulgated
additional corrective action regulations to codify the statutory
language of RCRA Sec. 3004(v), requiring corrective action for releases
beyond the facility boundary. EPA also established permit application
requirements necessary to support corrective action implementation, and
modified the corrective action requirements for underground injection
wells with RCRA permits-by-rule.
On July 27, 1990 (55 FR 30798), EPA proposed detailed regulations
to govern the RCRA corrective action program. The 1990 proposal was
designed to be the analogue to the CERCLA program's National Oil and
Hazardous Substances Pollution Contingency Plan (NCP). As such, it
addressed both technical (e.g., cleanup levels, remedy selection,
points of compliance) and procedural (e.g., definitions, permitting,
reporting) elements of the corrective action program. In the 1990
proposal, EPA emphasized the need for site-specific flexibility in
cleanup programs. The Agency stated, ``Because of the wide variety of
sites likely to be subject to corrective action, EPA believes that a
flexible approach, based on site-specific analyses is necessary. No two
cleanups will follow exactly the same course, and therefore, the
program has to allow significant latitude to the decision maker in
structuring the process, selecting the remedy, and setting cleanup
standards appropriate to the specifics of the situation.'' (See, 55 FR
30802.)
The 1990 proposal was the subject of significant public comment.
Although EPA has finalized only a few sections of the 1990
proposal,1 the bulk of the proposal is routinely used as guidance
during corrective actions.
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\1\ See 58 FR 8658, February 16, 1993, ``Corrective Action
Management Units'' where EPA finalized regulations addressing the
creation, management, and closure of units created specifically for
purposes of managing remediation wastes.
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B. Summary of Today's Notice
Today's Notice introduces EPA's strategy for promulgation of
corrective action regulations and requests public input on a variety of
issues and concepts associated with corrective action. To provide
context for potential revisions to the corrective action program and
because the Agency's philosophy and strategies have evolved in many
respects since 1990, today's Notice also includes a general status
report on the corrective action program and how it has grown since the
1990 proposal, and provides guidance on a number of topics not fully
addressed in 1990. Finally, today's Notice emphasizes the flexibility
inherent in the existing corrective action program, discusses steps EPA
is already taking to improve corrective actions and requests comments
on new approaches to expedite and simplify facility cleanups.
In Section I of today's Notice, EPA identifies the statutory and
regulatory basis of the corrective action program.
Section II of today's Notice introduces EPA's Subpart S Initiative.
Through the Subpart S Initiative the Agency intends to identify and
implement improvements to the protectiveness, responsiveness, speed and
efficiency of the corrective action program. Section II includes
discussions of the Subpart S Initiative objectives, outreach, and
schedule. It also includes discussions of major corrective action
program guidance and policy milestones that have occurred since 1990,
and the relationship of the Subpart S Initiative to other agency
rulemakings and initiatives.
In Section III, EPA discusses corrective action implementation,
describes how certain program elements have evolved since 1990, and
provides guidance on a number of topics that were not fully addressed
in the 1990 proposal. This section emphasizes areas of flexibility in
the current corrective action program and highlights innovative
approaches some program implementors and facility owners/operators have
used to expedite cleanups. Readers are urged to pay particular
attention to Section III in order to gain an overall understanding of
the Agency's latest thinking on corrective action implementation.
Section IV of today's Notice builds on the detailed discussions in
Section III by providing concise statements of EPA's corrective action
implementation goals and strategies.
In Section V of today's Notice, EPA requests comments and data on a
variety of issues to assist it in identifying and developing
improvements to the corrective action program. In some cases, the
Agency raises new concepts that would likely warrant re-proposing
regulations or developing new guidance documents; in other cases,
concepts were addressed in the 1990 proposal but are included in
Section V because the Agency is requesting additional comment and data
at this time.
II. Subpart S Initiative
EPA and the states have made considerable progress in implementing
the corrective action requirements; however, despite this progress, the
overall implementation of the corrective action program has been
subject to considerable criticism. States,
[[Page 19435]]
environmental groups and the regulated community have raised many
concerns, including: slow progress in achieving cleanup or other
environmental results; an emphasis on process and reports over actual
work in the field; unrealistic, impractical or overly conservative
cleanup goals; excessive and detailed oversight; reluctance to
authorize or recognize the work of state cleanup programs; and, lack of
meaningful public participation. EPA believes that many of these
concerns have been overstated; however, at the same time, it recognizes
that improvements to the corrective action program are necessary. EPA
and the states now have more than ten years experience in implementing
the corrective action requirements. EPA believes the time has come to
reevaluate the RCRA corrective action program to identify and implement
improvements to the program's speed, efficiency, protectiveness and
responsiveness, and to focus the program more clearly on environmental
results. The reevaluation effort is known as the Subpart S Initiative.
As part of the Subpart S Initiative, EPA has been working with
states and other stakeholders to develop a comprehensive strategy to
identify and develop improvements to the corrective action program and
promulgate final corrective action regulations. The Subpart S
Initiative involves assessment of the current corrective action
program, outreach to stakeholders, finalization of some elements of the
1990 proposal, development of new proposals and guidance documents, and
today's Notice.
EPA is committed to substantive consistency among its cleanup
programs. For that reason, the Subpart S Initiative is being
coordinated closely with the Superfund program, including the Superfund
administrative improvements efforts and Superfund reauthorization
activities.
A. Objectives
Taking into consideration corrective action implementation
experience, recent feedback from stakeholders, and the comments
received on the 1990 proposal, EPA has developed five objectives for
the Subpart S Initiative:
(1) Create a consistent, holistic approach to cleanups at RCRA
facilities;
(2) Establish protective, practical cleanup expectations;
(3) Shift more of the responsibilities for achieving cleanup goals
to the regulated community;
(4) Focus on opportunities to streamline and reduce costs; and,
(5) Enhance opportunities for timely, meaningful public
participation.
Implementation of these five objectives will involve new approaches
to corrective action and may necessitate significant revisions to the
existing corrective action program. In adopting any new approach, EPA
will not sacrifice protection of human health and the environment or
the meaningful involvement of the public and affected communities.
B. Outreach
EPA believes the experiences of states, the regulated community,
other Federal agencies, and environmental and public interest groups
will be tremendously valuable as it works to identify and develop
improvements to the corrective action program. Today's Notice reflects
the involvement of interested stakeholder groups, as discussed below.
EPA is committed to a continuing and meaningful dialogue with these
groups as the Subpart S Initiative develops. As the Subpart S
Initiative progress, EPA will continue to identify interested
stakeholder groups and invite their input and involvement.
1. States
In December and January 1995, EPA met twice with interested state
representatives to solicit their early input in the Subpart S
Initiative. In general, these state representatives advised that the
corrective action program: Retain considerable flexibility; emphasize
results over process; be generally consistent with the CERCLA program;
address consistency issues within the RCRA program (e.g., between
cleanups at SWMUs and regulated units); address risk assessment and
risk management, including ecological risk; empower states and expedite
state authorization; and, encourage stabilization without discouraging
final cleanups. State representatives also strongly advised against
finalizing corrective action regulations in pieces, favoring the
comprehensive approach reflected in today's Notice. The ongoing role of
the states in the Subpart S Initiative is discussed below.
2. Environmental and Public Interest Community
EPA wrote nine environmental and public interest groups requesting
their early involvement in the Subpart S Initiative. To date, EPA has
met with one environmental group, the Environmental Defense Fund (EDF).
The Environmental Defense Fund expressed support for changes in the
corrective action program to improve the speed and efficiency of
cleanups and increase opportunities for meaningful public
participation. Their suggestions include: tailoring the level of public
participation to the level of community interest; including
opportunities for public participation throughout the cleanup process;
using risk goals and clearly defined cleanup standards to make cleanups
more efficient; maintaining a throughout-the-plume/unit boundary
cleanup point of compliance; and, using deed restrictions at non-
residential cleanups. While EDF expressed general support for
consistency in technical matters between RCRA and CERCLA, they also
expressed the opinion that operating hazardous waste management
facilities, such as those typically addressed by RCRA corrective
action, have an ongoing responsibility to their communities and should,
perhaps, be held to higher cleanup standards than abandoned (i.e.,
Superfund) sites. EPA welcomes the continued involvement of EDF in the
Subpart S Initiative and will continue to look for opportunities to
involve other environmental and public interest groups.
3. Regulated Community
EPA met with and received written materials from a variety of
industry groups which offered their suggestions for improvements to the
corrective action program. In general, industry groups expressed
frustration with the pace and cost of corrective actions and what they
perceive as overly stringent cleanup criteria. Their suggestions
include increased reliance on performance standards, more emphasis on
non-residential future land use scenarios, and improved coordination
with other applicable cleanup authorities (e.g., the Superfund program
and state cleanup programs). EPA welcomes the continued involvement of
the regulated community in development of the Subpart S Initiative.
4. Other Federal Agencies
During Spring and Summer 1995, EPA held a series of meetings with
other Federal agencies, including, the Department of Defense (DOD), the
Department of Energy (DOE), the Department of Agriculture, the Council
on Environmental Quality (CEQ), and the Office of Management and Budget
(OMB). Many of these agencies own or operate facilities which are
subject to RCRA corrective action. During these meetings, EPA and the
other Federal agencies discussed potential improvements to the RCRA
corrective action and Superfund programs. EPA will continue these
discussions during development of the Subpart S Initiative.
The Department of Defense and the Department of Energy reviewed and
[[Page 19436]]
provided comments on a draft version of today's Notice and EPA met with
DOD and DOE representatives to discuss their comments and suggested
changes.
C. On-Going Role of the States
The states are the primary implementors of the corrective action
program. Because of this, EPA has actively solicited state input and
participation in the Subpart S Initiative and is developing the
Initiative in full partnership with the states. As of today's Notice,
thirteen states 2 have agreed to participate in the Subpart S
Initiative as co-regulators. During the co-regulation process, state
representatives participate actively in development of policy and
regulatory options and analyses. As discussed above, EPA has held two
meetings with state representatives to discuss development of the
Subpart S Initiative; three additional meetings and a fifty-state
review of any regulatory proposals are planned. In addition,
representatives of interested states participated actively in
development of today's Notice and reviewed and provided comment on
numerous drafts.
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\2\ These states are: Wisconsin, Texas, Georgia, Idaho, Florida,
Colorado, New York, California, Utah, Oklahoma, North Carolina,
Delaware, and Missouri.
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D. Strategy and Schedule
The Subpart S Initiative will include development of guidance and
policy documents and rulemaking. EPA intends to publish rule language
in fall 1997. In order to present the Agency's visions for the
corrective action program and regulations in totality, the 1997
publication will promulgate elements of the 1990 proposal that the
Agency believes do not need additional public review and will re-
propose other program elements. Based in part on comments received in
response to Section V.B of today's Notice, EPA will determine which
elements of the 1990 proposal will be finalized without further comment
and which elements will be re-proposed.
Guidance and policy development will play an important role in the
Subpart S Initiative. The balance between guidance and policy
development and rulemaking will be determined, in part, by comments
received on today's Notice. Section V.A of this Notice requests
specific recommendations for additional policy or guidance development.
E. Major Corrective Action Program Developments Since 1990
The Subpart S Initiative builds on several recent and important
developments in the corrective action program. Many of these program
developments are addressed in the EPA guidance documents discussed
below; other program developments were associated with promulgation of
the Corrective Action Management Unit (CAMU) regulations, also
discussed below. A complete list of corrective action guidance
documents is available in the ``RCRA Corrective Action Plan,'' EPA/520-
R-94-004, OSWER Directive 9902.3-2A, May 1994, included in the docket
for today's Notice.
1. Stabilization Initiative
EPA's early implementation of the corrective action program focused
on final, comprehensive cleanups at a limited number of facilities. As
EPA and states gained more experience, it became clear that, at many
sites, final cleanups were difficult and time-consuming to achieve and
that an emphasis on final remedies at a few sites could divert limited
resources from addressing ongoing releases and environmental threats at
many other sites. As a result, in 1991, the Agency established the
Stabilization Initiative as one of the primary implementation
objectives for the corrective action program. The goal of the
Stabilization Initiative is to increase the rate of corrective actions
by focusing on near-term activities to control or abate threats to
human health and the environment and prevent or minimize the further
spread of contamination. Through the Stabilization Initiative, the
Agency is seeking to achieve an increased overall level of
environmental protection by implementing a greater number of actions
across many facilities rather than following the more traditional
process of pursuing final, comprehensive remedies at a few facilities.
Controlling exposures or the migration of a release may stabilize a
facility, but does not necessarily mean that a facility is completely
cleaned up. At some stabilized facilities, contamination is still
present and additional investigations or remediation may eventually be
required; however, as long as the stabilization measures are
maintained, stabilized facilities should not present unacceptable near-
term risks to human health or the environment and program implementors
and facility owners/operators have the opportunity to shift their
resources (either at the stabilized facility or among facilities) to
additional health or environmental concerns. Stabilization actions
should be a component of, or at least consistent with, final remedies.
More information on the Stabilization Initiative is available in the
1991 guidance memorandum ``Managing the Corrective Action Program for
Environmental Results: The RCRA Facility Stabilization Effort'' and in
Section III.C.3 of today's Notice.
2. Environmental Indicators for Corrective Action
Critics of the corrective action program have often charged that
EPA focuses too much on administrative processes rather than actual
cleanups. As an example of this problem, critics cite Agency management
systems which often track the number of paperwork deliverables (e.g.,
work plans approved) rather than achievement of environmental results.
In response to these concerns and the Government Performance and
Results Act of 1993, EPA is moving the corrective action program away
from more traditional management systems and, consistent with a broader
Agency-wide effort, now focuses management of the corrective action
program on environmental indicators. Two specific environmental
indicators have been developed for the corrective action program. These
indicators are: Human Exposures Controlled Determination and
Groundwater Releases Controlled Determination. The environmental
indicators are facility-wide measures. Human Exposures Controlled is
attained when there are no unacceptable risks to humans due to releases
of contaminants at or from the facility subject to RCRA corrective
action. Groundwater Releases Controlled is attained when the migration
of groundwater contamination at or from the facility across designated
boundaries (these boundaries may be facility boundaries or specified
boundaries within a facility) is controlled.
The environmental indicators are not tied to specific program
activities or paperwork deliverables. In the course of implementing
final remedies, the environmental indicators will be achieved; however,
the implementation of stabilization measures can also result in
achieving the environmental indicators. EPA is striving to make the
corrective action program more performance based. Because the
environmental indicators focus on results, they can serve well as
performance measures for remedial activities. Further guidance on the
environmental indicators is available in the July 29, 1994 memorandum
``RCRIS Corrective Action Environmental Indicator Event Codes CA725 and
CA750,'' which has been placed in the docket for today's Notice.
[[Page 19437]]
EPA is committed to using the corrective action environmental
indicators to increase the efficiency of the corrective action program
by focusing on results. Although EPA has developed only two
environmental indicators for corrective action to date, additional
indicators may be developed to address factors such as ecological risk
or source control. EPA requests comments on the development of
additional environmental indicators in Section V.C.1 of today's Notice.
3. Corrective Action Plan
Another concern in the corrective action program has been
consistency. While no two cleanups will follow the exact same course,
EPA recognizes that some level of consistency in cleanup processes can
help to ensure that all cleanups will achieve the same overall level of
protection. The RCRA Corrective Action Plan or CAP (OSWER Directive
9902.3-2A, May 1994), provides guidance which program implementors and
facility owners/operators can use to develop and direct the specific
corrective action activities which might be necessary at any given
facility. The CAP provides an overall program implementation framework
and model scopes of work for site characterizations, interim actions,
evaluation of remedial alternatives and remedy implementation. Program
implementors and facility owners/operators can use these model scopes
of work when developing site-specific strategies, work plans, and
schedules of compliance.
The CAP is not meant to be a cleanup prescription. The model scopes
of work in the CAP present a range of activities which might be
necessary at a corrective action facility. Program implementors and
facility owners/operators should choose carefully from this range when
developing facility specific work plans.
4. CAMU Rule
Program implementors and facility owners/operators have long
recognized that certain RCRA Subtitle C hazardous waste requirements
can significantly complicate or delay cleanups when applied to
remediation wastes. To address this problem, EPA promulgated
regulations for corrective action management units (58 FR 8658,
February 16, 1993). The CAMU rule provides relief from specific RCRA
standards that can preclude desirable remediation options or
unnecessarily add to the cost of remedies (e.g., the RCRA land disposal
restrictions when applied to remediation waste) by creating a new type
of RCRA unit. EPA and authorized states may choose to designate a CAMU
for management of remediation waste during RCRA corrective actions and
other cleanups. When designating CAMUs, EPA and authorized states have
the flexibility to establish site-specific design, operating, closure
and post-closure requirements instead of using the existing RCRA
requirements for land-based units. Remediation wastes (i.e., media and
debris which contain hazardous waste or exhibit a hazardous waste
characteristic) may be consolidated into a CAMU before or after
treatment. In addition, remediation wastes may be treated in a CAMU or
moved (again, before or after treatment) between CAMUs at the same
facility without automatically triggering otherwise applicable RCRA
land disposal restrictions or minimum technology requirements.
The CAMU rule was challenged in 1993; however, the challenge has
been stayed pending publication of the final Hazardous Waste
Identification Rule for Contaminated Media (HWIR-Media). EPA expects
that the HWIR-Media rule will largely obviate the need for the CAMU
rule, and is planning to propose withdrawal of the CAMU regulations as
part of the HWIR-Media proposal (for a discussion of the HWIR-Media
proposal, see Section II.F.1 of today's Notice). In the meantime, CAMUs
may be used to support efficient and protective cleanups.
5. Other Developments
In addition to the examples discussed above, program implementors
and facility owners/operators are using the existing flexibility in the
corrective action program to explore a range of new approaches in an
effort to improve the corrective action process and expedite cleanups
at a facility-specific level. These include: using performance
standards to set goals for site investigations and cleanups;
encouraging innovative technical approaches; facilitating voluntary or
accelerated cleanups, when a facility owner/operator wants to move
ahead of a regulatory agency; the use of third-party oversight;
expanded public participation, including use of citizen advisory
boards; innovative coordination with or deferral to other programs,
including state cleanup programs; and, many other efforts. In
accordance with EPA's emphasis on consistency of results between the
RCRA and CERCLA programs, many of these approaches are being developed
in cooperation with the Superfund program or state remedial programs.
EPA encourages program implementors and facility owners/operators
to continue to explore new approaches to corrective action and to share
their successes and failures. Some of the innovative approaches which
have proved most successful at individual facilities are discussed
later in today's Notice; EPA is looking forward to receiving
information on other new approaches in response to today's Notice. One
of the purposes of today's Notice is to gather information on
successful facility-specific approaches to corrective action so EPA can
build on implementation experience as it identifies and develops
improvements to the national program during the Subpart S Initiative.
F. Relationship to Other Agency Initiatives and Rulemakings
EPA is involved in several rulemakings and other activities which
will have particular impact on the Subpart S Initiative. Coordination
with these other rulemakings and activities is ongoing.
1. HWIR Media
The Hazardous Waste Identification Rule for Contaminated Media
(HWIR-Media) is a regulatory reform proposal that reexamines the
application of many of the RCRA hazardous waste treatment and
management standards to contaminated environmental media (e.g., soil
and groundwater) managed during Agency or authorized state overseen
cleanups. Under current regulations, environmental media that contain
(or are contaminated by) hazardous wastes must be managed as hazardous
waste (this is known as the ``contained-in policy''). In developing the
HWIR-Media proposal, EPA, in partnership with the states, is examining
a number of reforms designed to allow program implementors to tailor
treatment and management requirements for contaminated media to site-
and media-specific conditions. EPA is proposing several types of
reforms and seeking comment on a number of alternatives. The Agency may
finalize any one or combinations of these reforms or alternatives.
The first major area of reform that EPA is considering would revise
the Land Disposal Restrictions (LDRs) Minimum Technological
Requirements (MTRs) and permitting requirements that apply to
contaminated media currently subject to hazardous waste management
requirements, to make them more appropriate for the types of
contaminated media and concerns typically addressed at cleanup sites.
Currently, large volumes of contaminated media are subject to
[[Page 19438]]
hazardous waste requirements, notably LDR, MTR and permitting, that
were originally designed for newly generated or process wastes, where
the concerns are different from those at cleanup sites.
More broadly, EPA is also proposing to exempt some contaminated
media from RCRA Subtitle C hazardous waste management requirements.
This reform would allow authorized states or EPA to determine
contaminated media management standards for those exempted media on a
site-specific basis. EPA is considering two exemption options. First,
EPA is considering exempting media by determining, often based on
management conditions, that the media do not contain hazardous wastes
(this is commonly known as the ``contained-out'' approach); second, EPA
is considering exempting media only if certain conditions were met
(this is commonly known as the ``conditional exclusion'' approach).
Under the options that would exempt only some contaminated media from
hazardous waste management requirements, EPA is proposing to use a set
of constituent concentrations known as a ``Bright Line'' to divide the
media that would and would not be eligible for exemption. Media with
concentrations of constituents below Bright Line concentrations would
be eligible for exemption; media with constituent concentrations above
the Bright Line would not be eligible. Finally, in the HWIR-Media
proposal, EPA is requesting comment on exempting all cleanup wastes,
including contaminated media, sludges, debris, and other wastes managed
during the course of a cleanup, based on a conditional exclusion. Under
this option, authorized states or EPA would set all management and
treatment requirements for cleanup wastes on a site-specific basis.
The HWIR-Media proposal in particular will complement the Subpart S
Initiative by potentially providing program implementors with the
flexibility to tailor requirements for management of contaminated media
to the risks posed by any given medium and the circumstances at any
given corrective action facility.
2. Post-Closure Rule
EPA has long recognized the need to more effectively integrate
corrective action and closure activities. Toward this end, the Agency
proposed a rule entitled ``Standards Applicable to Owners and Operators
of Closed and Closing Hazardous Waste Management Facilities; Post-
Closure Permit Requirement; Closure Process; State Corrective Action
Enforcement Authority'' (59 FR 55778, November 8, 1994). In this
notice, the Agency proposed revisions to the current requirements
applicable to facilities with closed and closing land disposal units,
and revisions to the requirements for state authorization for
corrective action. These provisions, described in more detail below,
were proposed as part of the Agency's efforts to create a consistent
approach to cleanups at RCRA facilities.
a. The Post-Closure Permit Requirement. The current regulations at
40 CFR Part 270.1(c) require owners and operators of surface
impoundments, landfills, land treatment units, and waste pile units
that received wastes after July 26, 1982, or that certified closure
after January 26, 1983 to obtain a post-closure permit for the
facility, unless they demonstrate closure by removal at those units.
For facilities that did not receive an operating permit, and closed
under interim status standards, this post-closure permit serves to
impose several critical statutory and regulatory requirements,
including the requirements for corrective action.
The November 8, 1994 proposal would allow a regulatory agency
(e.g., EPA or an authorized state) to address these facilities using
the best available regulatory or enforcement authority, instead of
requiring that agencies issue post-closure permits in all cases. While
the proposal would not otherwise modify the applicable cleanup
requirements at these facilities, it would remove the requirement that
they be imposed through the post-closure permitting process. Under the
proposal, a regulatory agency could require post-closure care
(including corrective action) at the facility under an enforcement
mechanism, a state cleanup authority, or Federal Superfund authority.
This flexibility contributes to the Agency's efforts in the Subpart S
Initiative.
b. Applicability of 40 CFR Parts 264 and 265 to Regulated Units
Requiring Corrective Action. Under the current regulations, the
requirements that apply to closed and closing land disposal units
depend on their legal status. Regulated units, defined in 40 CFR 264.90
as surface impoundments, waste piles, land treatment units, or
landfills that received waste after July 26, 1982, are subject to the
fairly specific closure, post-closure, financial assurance, groundwater
monitoring and corrective action requirements of 40 CFR Parts 264 and
265. Non-regulated solid waste management units are not subject to 40
CFR Parts 264 and 265; consequently, environmental risks at those units
are determined and addressed on a site-specific basis through the
corrective action process.
Despite this regulatory distinction, these units are often
indistinguishable in terms of environmental risk. EPA is concerned that
this dual regulatory scheme can, in some cases, limit its authority to
determine the best remedy at regulated units. In the November 8, 1994
proposal, the Agency expressed this concern, and solicited comment on
whether the regulations should be modified to give overseeing agencies
the discretion to remove or modify all or part of the Part 264 and 265
requirements described above at a facility that is undergoing cleanup
using the RCRA corrective action process.
c. State Corrective Action Enforcement Authority. Under the current
Federal authorization process, states are required to obtain
authorization for implementing provisions of HSWA, such as Section
3004(u), to address corrective action at permitted facilities. However,
states have never been required to obtain authority to address
corrective action at interim status facilities. On November 8, 1994,
EPA proposed that states be required to upgrade their judicial or
administrative enforcement authority to respond to releases of
hazardous waste or hazardous constituents at interim status facilities
as provided by Section 3008(h). This provision was designed to provide
consistent and complete delegation of the corrective action program to
states.
EPA is completing its review of comments on the proposed provisions
and plans to proceed with promulgation of the final rule in the near
future.
3. RCRA Statutory Reform
On March 16, 1995 the President committed to identify high cost,
low benefit provisions of the Resource Conservation and Recovery Act
(RCRA) for legislative reform. After an extensive stakeholder outreach
process, the Administration selected two issues. The first issue for
legislative reform, an exemption for certain low risk wastes from
costly regulation under RCRA's land disposal restrictions program, was
signed into law--the Land Disposal Flexibility Act--by the President on
March 26, 1996.
The second topic identified for legislative reform was the
application of RCRA hazardous waste management requirements to cleanup
wastes. The Administration currently is discussing with stakeholders
and Congress the possible development of bipartisan legislation to
expedite the safe and cost-effective management of cleanup wastes that
are currently subject to RCRA
[[Page 19439]]
hazardous waste management requirements. In addition to RCRA cleanup
sites, the type of reform being discussed would benefit site cleanups
under Superfund, Brownfield and State voluntary programs.
4. Improvements to the Procedures for Authorization of State Hazardous
Waste Program Revisions
Under RCRA Section 3007, EPA is charged with authorizing
equivalent state hazardous waste programs including corrective action
programs. Authorized states administer and enforce the RCRA program
within the state in lieu of the Federal program (see 40 CFR Part 271);
authorized states have primary enforcement responsibility, although EPA
retains enforcement authority under RCRA sections 3008, 7003, and 3013.
Following their initial authorization, states are required to
periodically revise their hazardous waste programs to remain equivalent
to the Federal program. Since EPA is continually revising the RCRA
program in response to statutory changes, court ordered deadlines and
evolving priorities, states are continually updating their authorized
programs. Preparation, review and approval of changes to authorized
state hazardous waste programs represents a significant workload for
states and EPA. In addition, states have often expressed the concern
that EPA review of changes to authorized hazardous waste programs is
too detailed, resource intensive, and time consuming. To increase the
pace and efficiency of authorization of state program revisions and
respond to state concerns, EPA proposed changes to the regulations for
processing state program revision applications in the Land Disposal
Restrictions Phase IV rule (60 FR 43654, August 22, 1995). Additional
provisions to streamline authorization of state program revisions are
under consideration for inclusion in the HWIR-Media rule, currently
under development. Improvements proposed in the LDR Phase IV rule and
under consideration for the HWIR-Media rule include: creating a tiered
approach to tailor authorization to the complexity and impact of the
program revisions at issue; increasing reliance on state
certifications; and placing more emphasis on time-frames for processing
of authorization applications. Improvements to the procedures for state
program revisions would apply to all state program revisions, including
revisions made necessary by promulgation of corrective action
regulations.
5. Superfund Reauthorization
As a general philosophy, EPA believes that the RCRA and CERCLA
remedial programs should operate consistently and result in similar
environmental solutions when faced with similar circumstances.
Currently, Congress is considering legislation to reauthorize CERCLA.
If CERCLA is amended, EPA believes that parallel changes in the
corrective action program should generally be adopted. Changes to the
CERCLA program which might impact the RCRA corrective action program
include new approaches to setting cleanup standards and factoring risk
into remedial decision making.
6. Superfund Administrative Improvements and Reforms
Independent of reauthorization of the CERCLA statute, EPA's
Superfund program has undertaken a number of administrative initiatives
to streamline the Superfund program and increase the fairness,
effectiveness, and efficiency of CERCLA cleanups. Several of the
proposals developed as part of the administrative reform and
improvement efforts also apply to RCRA cleanups, as discussed below.
a. Guidance on Land Use. On May 25, 1995, EPA issued a Directive
titled, ``Land Use in the CERCLA Remedy Selection Process.'' The
directive has two primary objectives. First, to promote early
discussions between EPA and local land use planning authorities, local
officials, and the public regarding reasonably anticipated future land
uses. Second, to promote the use of the information from those
discussions to formulate realistic assumptions regarding future land
use, and to clarify how land use assumptions influence risk assessment,
development of remedial alternatives, and remedy selection.
The directive was developed primarily to address land use
considerations under the CERCLA program; however, the principle of
early and complete involvement of stakeholder groups to develop
realistic land use assumptions is equally applicable to the RCRA
corrective action program. EPA recognizes that RCRA facilities are
often industrial properties that are actively managed, rather than the
abandoned sites typically addressed under CERCLA. Because of this
consideration, the directive stated that non-residential use
considerations might be especially appropriate at many RCRA corrective
action facilities. Consideration of non-residential land use in RCRA
corrective actions was addressed in the 1990 proposal and is discussed
further in Sections III.C.5.j and V.E.1 of today's Notice.
b. Soil Screening Guidance. In December 1994, EPA issued a draft
``Superfund Soil Screening Guidance,'' (SSG) for public review and
comment. The SSG was developed to accelerate decision making at CERCLA
and other cleanup sites by focusing investigations on exposure pathways
and contaminated areas of concern and eliminating certain pathways,
areas, and contaminants not of concern from more detailed assessments.
The SSG provides a framework for developing site-specific screening
levels for residential-based exposure scenarios.
Specific soil screening levels (SSLs), derived in accordance with
the SSG, are defined as contaminant concentrations in soil below which
no further action or study would generally be warranted under CERCLA.
They are not intended to be cleanup levels. According to the SSG, where
soil contaminant concentrations equal or exceed SSLs, further
assessment, but not necessarily a cleanup, would likely be warranted.
EPA is evaluating comments on the draft guidance and intends to
issue final soil screening guidance in the near future. The Agency
anticipates that the SSG may also be used to develop action levels for
certain RCRA corrective action facilities. For more information on the
role of action levels during corrective actions, see Section III.C.2.e
of today's Notice.
c. Presumptive Remedies. The Superfund program began developing
presumptive remedy guidance in 1991, to use past experience to
streamline cleanups. Presumptive remedies are preferred technologies
for common categories of sites, based on historical patterns of remedy
selection and EPA's scientific and engineering evaluation of
performance data on technology implementation. The Agency expects that
presumptive remedies will be used at all appropriate sites, including
RCRA facilities, to help ensure consistency in remedy selection and
implementation and to reduce the cost and time required to investigate
and remediate similar types of sites. Several presumptive remedy
guidance documents are available and have been placed in the docket for
today's Notice, including: Presumptive Remedies: Policies and
Procedures; Presumptive Remedy for CERCLA Municipal Landfill Sites;
Presumptive Remedies: Site Characterization and Technology Selection
for CERCLA Sites with Volatile Organic Compounds in Soils; and,
Presumptive Remedies for Soils, Sediments and Sludges at Wood Treating
Sites. Future presumptive
[[Page 19440]]
remedy guidance documents may address sites with groundwater
contamination, sites contaminated with polychlorinated biphenyl
compounds (PCBs), and manufactured gas sites.
d. Community Based Remedy Selection. In an effort to increase
community involvement, EPA plans to pilot a new community-based
Superfund remedy selection process. Under this process, EPA will assist
community groups, local governments and other stakeholders in
developing consensus and becoming more directly involved in remedy
selection at select Superfund sites.
During the first half of fiscal year 1996, EPA will develop
guidelines and options for community-based remedy selection pilot
programs at specific sites. These pilot programs will empower affected
parties to play a direct role in finding a protective, cost-effective
remedy for a Superfund site in their community, inform affected parties
of the applicable statutory and regulatory requirements, and improve
community understanding and acceptance of Superfund remedies. EPA will
use the results of the Superfund community-based remedy selection pilot
programs as it works to improve public participation at RCRA corrective
action facilities.
7. Brownfields Initiative
EPA developed the Brownfields Economic Redevelopment Initiative to
help communities revitalize abandoned, idled, or under-used industrial
and commercial sites where expansion or redevelopment is complicated by
environmental contamination. Through the Brownfields Action Agenda, the
Agency committed to fund up to 50 Brownfield Pilot Programs to explore
brownfield characterization and redevelopment strategies at the local
level. The brownfields pilots will test redevelopment models, direct
special efforts toward removing regulatory barriers without sacrificing
protectiveness, and facilitate coordinated environmental cleanup
efforts at the Federal, state and local levels. The Pilots are intended
to provide EPA, states, tribes, municipalities, and communities with
useful information and strategies as they continue to seek new methods
to promote a unified approach to site assessment, environmental
cleanup, and redevelopment. To date, EPA has awarded 40 pilots.
EPA anticipates that many approaches to cleanup and site
redevelopment evolving from the Brownfields Initiative will have direct
application to the corrective action program and the Subpart S
Initiative.
8. Environmental Justice
Executive Order 12898, ``Federal Action to Address Environmental
Justice in Minority Populations and Low-Income Populations,'' directs
each Federal Agency to ``. . . make achieving environmental justice
part of its mission by identifying and addressing, as appropriate,
disproportionately high and adverse human health and environmental
effects of its programs, policies and activities on minority
populations and low income populations.'' In response to the Executive
Order and to concerns voiced by many groups outside the Agency, EPA
issued a Directive on September 21, 1994 which required that
environmental justice issues be considered at all stages of policy,
guidance and regulation development.
EPA has identified four main areas of environmental justice
concerns within the Subpart S Initiative: (1) outreach to stakeholders,
including members of affected communities, during the rulemaking
process; (2) public participation on a site-specific level during the
corrective action process; (3) public participation in future land-use
and associated remedial decisions; and (4) ensuring the continued
effectiveness of any institutional controls. The Agency recognizes that
discussions of streamlining, such as those in today's Notice, often
raise concerns in environmental justice communities. The Agency remains
committed to identifying and addressing environmental justice concerns
and to expanding public participation in the corrective action process,
and would welcome the involvement of the environment justice community
in development of the Subpart S Initiative.
9. Permits Improvement Team
In July 1994, EPA organized a group of state, tribal and local
government officials to examine and propose improvements to EPA's
permit programs. This group is known as the Permits Improvement Team.
The Permits Improvement Team is examining ways to streamline the
permitting process, exploring alternatives to individual permits, and
evaluating ways to enhance public participation in permitting. For RCRA
corrective action, the emphasis is on addressing RCRA and non-RCRA
facilities in order of environmental priority, rather than having a
state's priorities skewed by the RCRA permit process. For example, the
RCRA permit could include a general provision to require compliance
with the state's existing environmental cleanup program. Any changes to
the RCRA permitting program that result from the Permits Improvement
Team's efforts will be considered as EPA implements the Subpart S
Initiative.
III. Corrective Action Implementation
As discussed in Section II of today's Notice, EPA generally uses
the 1990 corrective action proposal, supplemented by later guidance, as
a guideline for corrective action implementation. The 1990 proposal was
intended to support a flexible approach to corrective action.
Unfortunately, EPA believes the proposal has at times been interpreted
too narrowly, and much of the intended flexibility has been under used.
In addition, the nature of the corrective action program and some of
EPA's positions have evolved since 1990.
For the benefit of those involved with the corrective action
program, and to provide context for the requests for comment in Section
V of today's Notice, this section provides a general status report on
the corrective action program, and how it has evolved since the 1990
proposal and includes guidance on a number of topics not fully
addressed in 1990. It also emphasizes the flexibility inherent in the
current corrective action program and encourages program implementors
and facility owners/operators to take advantage of this flexibility to
improve the corrective action process and expedite cleanups.
A. Program Management Philosophy
More than 5,000 facilities are subject to RCRA corrective action,
over three times the number of sites on CERCLA's National Priorities
List (NPL). The degree of investigation and subsequent corrective
action necessary to protect human health and the environment varies
significantly across these facilities. Some facilities may require no
cleanup at all or only minor corrective action, while others are as
complex and highly contaminated as any Superfund site. To account for
the variety of corrective action facilities and site-specific
circumstances, EPA has emphasized a flexible, facility-specific
approach to corrective action. Few cleanups will follow exactly the
same course; therefore, program implementors and facility owners/
operators must be allowed significant latitude to structure the
corrective action process, develop cleanup objectives, and select
remedies appropriate to facility-specific circumstances. At the same
time, a number of basic operating principles
[[Page 19441]]
guide corrective action program implementation and development.
(1) Corrective Action Decisions Should Be Based on Risk
As in most EPA programs, the Agency's fundamental goal in the
corrective action program is to control or eliminate risks to human
health and the environment. Risk-based decision making is especially
important in the corrective action program, where it should be used to
ensure that corrective action activities are fully protective given
reasonable exposure assumptions and consistent with the degree of
threat to human health and the environment at a given facility.
(2) Program Implementation Should Focus on Results
The purpose of the corrective action program is to stabilize
releases and clean up RCRA facilities in a timely manner, not to ensure
compliance with or fulfillment of a standardized process. Program
implementors and facility owners/operators should focus on
environmental results rather than process steps and ensure that each
corrective action related activity at any given facility directly
supports cleanup goals at that site. In focusing on results, program
implementors are encouraged to use innovative approaches to management
and oversight.
(3) Interim Actions and Stabilization Should Be Used To Reduce Risks
and Prevent Exposures
A primary implementation strategy of the corrective action program
is to focus resources first on stabilizing continuing releases and
controlling exposure at facilities undergoing corrective action. Once a
facility is stabilized, Agency oversight at that facility can be
reduced and resources shifted to other facilities of concern. By
focusing on stabilizing many facilities, rather than pursuing a final
cleanup at a few facilities, EPA can achieve a greater overall level of
human health and environmental protection in the near-term.
(4) Activities at Corrective Action Facilities Should Be Phased
Significant efficiencies can be gained by phasing corrective action
at individual facilities to focus on areas of the facility that
represent the greatest risk to human health and/or the environment.
Phasing allows information obtained from previous phases to be used for
planning and refining subsequent investigations or responses. Using a
phased approach, response actions can be taken at some high-priority
areas of the facility while other lower-priority areas are addressed at
a later time.
(5) Program Implementation Should Provide for Meaningful Inclusion of
All Stakeholders
EPA is committed to including all stakeholders in the corrective
action process. Stakeholders are included in both facility-specific
decision making through public participation activities and in the
development of the national corrective action program. The Agency
believes stakeholder involvement is essential in all corrective action
cleanups, regardless of the oversight mechanism used (e.g., order,
permit, state authority, voluntary action).
(6) Corrective Action Obligations Should Be Addressed Using the Most
Appropriate Tool for Any Given Facility
EPA recognizes that there are many mechanisms or tools which can be
used to ensure appropriate corrective action at any given facility,
including RCRA orders or permits, state cleanup orders, and voluntary
cleanup programs. Each mechanism has advantages and disadvantages when
applied to individual facilities. Program implementors and facility
owners/operators should carefully consider these advantages and
disadvantages when choosing a corrective action mechanism.
(7) States Will Be the Primary Implementors of the Corrective Action
Program
Since corrective action requirements will be, predominantly,
implemented by states, EPA is committed to full and meaningful state
involvement in development of corrective action implementation
strategies, policy, guidance and regulations.
B. Scope and Definitions
Corrective action requirements apply at hazardous waste treatment,
storage and disposal facilities (TSDFs). These include permitted
facilities and facilities that have, have had, or should have had RCRA
interim status. This collection of facilities is typically referred to
as the ``corrective action universe.'' Corrective action may be
required for releases of hazardous waste or hazardous constituents from
these facilities, as necessary to protect human health and the
environment. EPA does not generally require corrective action at
facilities which are issued land treatment demonstration permits,
emergency permits, permits-by-rule for ocean disposal, or research,
development and demonstrations permits unless these facilities
otherwise become subject to RCRA operating or post-closure permitting
requirements.
The 1990 proposal established EPA's views on the scope and
applicability of RCRA corrective action authorities. Although EPA's
views have largely remained unchanged in this area, there have been
several important refinements or developments, as discussed below.
1. Concept of Parity
Most facilities in the RCRA corrective action universe are
potentially subject to cleanup under numerous cleanup authorities,
including state or Federal Superfund authorities. The potential for
overlapping application of these authorities can cause confusion and
concern in the regulated community and among state and Federal
regulators. In the 1990 proposal, EPA stated that one of the Agency's
primary objectives was ``to achieve substantial consistency with the
policies and procedures'' of the Superfund remedial program. The logic
behind this concept is that, since both programs address cleanup of
potential and actual releases, both programs should arrive at similar
remedial solutions. EPA's position is that any procedural differences
between RCRA and CERCLA should not substantively affect the outcome of
remediation.
Generally, cleanup of any given site or area at a facility under
RCRA corrective action or CERCLA will substantively satisfy the
requirements of both programs. We believe that, as a general matter,
RCRA and CERCLA program implementors can defer cleanup activities from
part or all of a site to one program with the expectation that no
further cleanup will be required under the other program. For example,
when investigations or studies have been completed under one program,
there should be no need to review or repeat those investigations or
studies under another program. Similarly, a remedy that is acceptable
to one program can be presumed to meet the standards of the
other.3 The same principle should apply to authorized state
corrective action programs and state CERCLA analogous programs. Over
half the states have Superfund-like authorities. In some cases, these
authorities may be substantively equivalent in scope and effect to the
Federal CERCLA program, and therefore are likely to be substantially
equivalent to the RCRA corrective action program.
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\3\ In some cases specific releases or constituents are not
``solid wastes'' under RCRA. For example, RCRA excludes from the
definition of solid waste certain source, special nuclear, or
byproduct material as defined by the Atomic Energy Act 42 U.S.C.
Sec. 2011.
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[[Page 19442]]
EPA emphasized the concept of parity in a recently issued policy
for deleting RCRA facilities from the NPL and deferring their cleanup
to the RCRA corrective action program (60 FR 14641), available in the
docket for today's Notice.4 EPA is planning to issue additional
guidance on RCRA and CERCLA parity in an upcoming policy memo,
``Coordination of RCRA/CERCLA Activities'' and through the inter-agency
and state ``Lead Regulator Workgroup.''
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\4\ The RCRA deletion policy does not pertain to Federal
Facilities, even if such facilities are also subject to RCRA
Corrective Action; however, program implementors and facility
owners/operators are encouraged to use interagency agreements to
eliminate duplication of effort, including oversight, at Federal
facilities.
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2. Voluntary Cleanup
EPA strongly encourages voluntary corrective actions. As discussed
in the 1990 proposal, voluntary cleanups have a number of advantages,
including timeliness, flexibility, and efficient use of facility owner/
operator and Agency resources. Unfortunately, representatives of the
regulated community have, on occasion, complained that procedural
barriers have delayed cleanups they were willing to undertake
voluntarily. Over the last few years, EPA and the states have taken
significant steps to address this concern and to further enc
FR Doc. 96-9707 Corrective Action for Releases From Solid Waste Management Units at Hazardous Waste Management Facilities
ourage and
facilitate voluntary actions. For example, EPA is planning to issue
guidance on the use of state voluntary cleanup programs to address
contamination at sites that may be subject to cleanup under the
Comprehensive Environmental Response, Compensation, and Liability Act
including hazardous waste generators, unregulated by RCRA corrective
action requirements. The Guidance for Development of Memoranda of
Agreement (MOA) Language Concerning State Voluntary Cleanup Programs is
being developed in partnership with interested states and will outline
general principles which EPA will use when deciding whether to endorse
a state voluntary cleanup program and to assure private parties that
subsequent Federal action under CERCLA will not be taken except under
limited circumstances.
The same general principles established in the CERCLA MOA guidance
may apply to the use of state voluntary cleanup programs at facilities
subject to RCRA corrective action; however, because of distinctions in
statutory requirements, consideration of additional factors may be
required of those programs. Issues associated with voluntary cleanups
at facilities subject to RCRA corrective action, including the use of
state voluntary cleanup programs, are discussed in Section V.D.3 of
today's Notice.
3. Definitions
The 1990 proposal included definitions for a number of terms which
help to further define the applicability of RCRA corrective action.
Pending final action on the proposal, EPA has generally continued to
interpret these terms consistently with the proposal; however, as EPA
has gained experience with applications in particular cases, it has
refined its interpretations in some respects. The following discussion
highlights the way in which these issues have been addressed in some
specific situations (e.g., cases decided by the EPA Environmental
Appeals Board (EAB)).
a. Facility. Under RCRA Sec. 3004(u), corrective action is required
for releases form solid waste management units at facilities seeking
RCRA permits. The 1990 proposal defined ``facility'' as ``all
contiguous property under the control of the owner or operator seeking
a permit under Subtitle C of RCRA.'' This definition was finalized when
the rule on corrective action management units (CAMUs) was promulgated
(58 FR 8658, February 16, 1993) and is now codified at 40 CFR 260.10.
For reasons discussed in the 1990 proposal, the term ``facility'' for
corrective action purposes is separate and substantively different from
the facility definition for other RCRA purposes.
A number of issues continue to arise regarding the application of
the facility definition. A common issue is whether or not a certain
parcel is considered ``contiguous'' for purposes of the corrective
action facility definition. One such situation is the case of two
parcels under common ownership but separated by a road or public right
of way. In the 1990 proposal, EPA indicated it would interpret such
parcels to constitute a single facility for purposes of corrective
action. This approach was recently accepted by the EAB, which held that
two parcels were a single facility where they were separated by a
privately owned railroad line (In re Exxon Co., USA, RCRA Appeal No.
94-8 (EAB May 17, 1995)).
Another common scenario involves two geographically separated
parcels under common ownership that are connected by ditches, bridges,
or other links under the control of the facility owner/operator. In the
Exxon permit appeal, the EAB noted the fact that the two parcels (which
it found to be ``contiguous'' in any case) were also connected by a
sewer system collecting waste water from different parts of the
facility. It pointed out that in an earlier case, evaporation ponds
three miles from a refinery were treated as part of the same facility
because they were linked to the refinery by a drainage ditch controlled
(although not owned) by the same party. (See, In re Navajo Refining
Co., RCRA Appeal No. 88-3 (Adm'r June 27, 1989)). In a separate final
RCRA section 3008(h) order, EPA has determined that two parcels on
opposite sides of a river, but connected by a trestle, constitute a
single facility for corrective action purposes. (See, In re Sharon
Steel Corp., Docket No. RCRA III-062-CA (Region III).)
The 1990 proposal requested comment on how the definition of
facility should apply where a large parcel is owned by one party who
leases a small portion to another party for a RCRA-permitted facility.
In the proposal, EPA indicated that it would consider corrective action
requirements to extend to SWMUs throughout the larger parcel. At the
same time, EPA recognizes that there are differing views as to the
policy merits of this interpretation and invites further comment in
section V.C.2 of today's Notice.
b. Release. The definition of release for corrective action was
first discussed in the 1985 HSWA codification rule (50 FR 28702, July
15, 1985). In the 1985 rule, EPA wrote that the definition of release
for corrective action should, at a minimum, be as broad as the
definition of release under CERCLA. Accordingly, EPA has interpreted
the term release to mean ``any spilling, leaking, pumping, pouring,
emitting, emptying, discharging, injecting, escaping, leaching, dumping
or disposing into the environment.'' (See, 50 FR 28713, July 15, 1985.)
In the 1990 proposal, EPA clarified that the definition of release also
includes abandoned or discarded barrels, containers, and other closed
receptacles containing hazardous wastes or constituents and that it
could include releases that are permitted under other authorities, such
as the Clean Water Act. EPA continues to adhere to these
interpretations of the term ``release.''
c. Solid Waste Management Unit. In 1990, EPA proposed to define the
term ``solid waste management unit'' or ``SWMU'' to mean, ``Any
discernible unit at which solid wastes have been placed at any time,
irrespective of whether the unit was intended for the management of
solid or hazardous waste. Such units include any area at a facility at
which solid wastes have been routinely and systematically released.''
Pending resolution of the 1990 proposal, EPA has used this definition
in
[[Page 19443]]
corrective action implementation. The inclusion of units not
specifically intended for the management of solid or hazardous waste is
supported by the legislative history of RCRA sections 3004 (u) and (v),
and this point has been applied in decisions by the EAB. (See, e.g., In
re General Motors Corp., RCRA Appeal No. 90-24 (EAB Nov. 6, 1992).)
As discussed in the 1990 proposal, not all areas where releases
have occurred are considered SWMUs. In the 1990 proposal, EPA indicated
a one-time spill which had been adequately cleaned up would not
constitute a SWMU; on the other hand, a location at which wastes or
other materials were released in a routine and systematic manner (such
as a loading area where minor spills or leaks occurred routinely over
time) would be a SWMU. The 1990 proposal indicated that industrial
sewers used for collecting wastes would constitute SWMUs. This
interpretation, which was based in part on earlier decisions in permit
appeals, has been affirmed by the EAB in In re Amoco Oil Co., RCRA
Appeal No. 92-21 (EAB Nov. 23, 1993).
The definition of a SWMU is often a point of disagreement when
corrective action permits or orders are issued. Facility owners/
operators and representatives of the regulated community often argue
that Congress intended the RCRA corrective action program to be focused
on waste management units (i.e., SWMU) and that non-waste-management
related releases (e.g., spills) should be addressed by other cleanup
programs or authorities. EPA notes that authority exists for requiring
corrective action for releases that are not attributable to SWMUs.
Given the legislative history of RCRA section 3004(u), which emphasizes
that RCRA facilities should be adequately cleaned up, in part, to
prevent creation of new Superfund sites, EPA believes that corrective
action authorities can be used to address all unacceptable risks to
human health or the environment from RCRA facilities. In the permitting
context, remediation of non-SWMU related releases may be required under
the ``omnibus'' authority (see 40 CFR 270.32(b)(2)) which allows EPA to
impose such permit conditions as are necessary to protect human health
and the environment. In other contexts, orders under RCRA sections
3008(h) or 7003 may require remedial action to address releases
regardless of whether a SWMU is present. Therefore, extended debate or
litigation over a particular SWMU designation will in many cases be
unproductive for all parties and, as a general principle, EPA
discourages debate on these issues, believing that discussions should
more properly focus on whether there has been a release that requires
remediation.
To reflect a more holistic approach, permits and orders often use
the term ``area of concern'' to refer to releases which warrant
investigation or remediation under the authorities discussed above,
regardless of whether they are associated with a specific SWMU as the
term is currently used. For example, when an overseeing agency believes
one-time spills of hazardous waste or hazardous constituents have not
been adequately cleaned up, these releases are often addressed as areas
of concern.
d. Hazardous Waste and Hazardous Constituent. RCRA section 3004(u)
requires corrective action for releases of ``hazardous wastes or
constituents.'' As discussed in the 1990 proposal, EPA interprets the
term ``hazardous waste,'' as used in RCRA section 3004(u) to include
all wastes that are hazardous within the statutory definition in RCRA
section 1004(5), not just those that are either listed or identified by
EPA pursuant to RCRA section 3001.
EPA also used the 1990 proposal to discuss use of the phrase ``or
constituents'' in RCRA section 3004(u). EPA views this phrase as
significant in two ways. First, it indicates that Congress was
particularly concerned that, within the broad category of wastes that
might be ``hazardous'' within the statutory definition, the corrective
action authority should be used to address the specific subset of
``hazardous constituents.'' Second, it indicates that the corrective
action authority was not intended to be limited to hazardous waste, and
extends to hazardous constituents regardless of whether they also fall
within the term ``hazardous waste,'' or whether they were derived from
hazardous waste. Under this interpretation, constituents that were
contained within nonhazardous solid wastes may be addressed through
corrective action.
C. Corrective Action Process
The corrective action process discussed in the 1990 proposal was
structured around five elements common to most cleanup activities:
initial site assessment, site characterization, interim actions,
evaluation of remedial alternatives, and implementation of the selected
remedy. These elements typically occur, to one degree or another,
during most cleanups. As discussed in the 1990 proposal, EPA emphasizes
that no one approach to implementing these cleanup elements is likely
to be appropriate for all corrective action facilities; therefore, a
successful corrective action program must be procedurally flexible. In
addition, these cleanup elements should not become ends in themselves;
EPA continues to encourage program implementors and facility owners/
operators to focus on the desired result of a cleanup rather than a
mechanistic cleanup process. These five elements should be viewed as
evaluations necessary to make good cleanup decisions, not prescribed
steps along a path.
1. Initial Site Assessment
The first element in most cleanup programs is an initial site
assessment. During the initial site assessment information is gathered
on site conditions, releases, potential releases, and exposure pathways
to determine whether a cleanup may be needed and to identify areas of
potential concern. Overseeing agencies may also use initial site
assessments to set relative priorities between sites and allocate
oversight and other resources.
In the CERCLA program, the initial site assessment is called a
Preliminary Assessment/Site Investigation, or PA/SI; in the corrective
action program, it is referred to as a RCRA Facility Assessment or RFA.
During an RFA, an overseeing agency typically compiles existing
information on environmental conditions at a given facility and, as
necessary, gathers additional facility-specific information on solid
waste management units and other areas of concern, releases, potential
releases, release pathways, and receptors. Information gathered during
an RFA usually forms the basis for initiating full scale site
characterization
a. Facility Owners/Operators May Gather RFA Information. At the
time to today's Notice, EPA and the states have completed 3,534 RFAs at
RCRA facilities. In the past, EPA has been reluctant to allow facility
owners/operators to conduct RFAs because of concern over the adequacy
of the facility submissions; however, by now the RFA is a well
developed process and EPA believes it may be more reasonable to accept
the work of facility owners/operators. Where RFAs have not yet been
completed, facility owners/operators may choose to conduct their own
site assessment and submit the report to EPA for review. If EPA
believes the site assessment is adequate, the site assessment may be
approved and adopted as the RFA for the facility. In the same way, when
an RFA was completed some years ago, a facility owner/operator might
conduct a site assessment to update the RFA and submit it to EPA for
review, approval
[[Page 19444]]
and adoption as an RFA update. Facility owners/operators who choose to
conduct or update their own RFAs should ensure that they address all
solid waste management units and other areas of concern at the
facility. Guidance on the scope of RFAs is available in ``RCRA Facility
Assessment (RFA) Guidance'' EPA/530/SW-86/053, PB87-107769, October
1986, which has been placed in the docket for today's Notice. Facility
owners/operators who want to obtain a copy of the RFA conducted for
their facility should contact the appropriate EPA Regional Office or
their authorized state.
b. Release Assessment. Release assessments (sometimes referred to
as Phase 1 assessments) are used to confirm or reduce uncertainty about
solid waste management units, areas of concern, and potential releases
identified during the initial site assessments. Under the corrective
action process as originally conceived, program implementors and
facility owners/operators would typically move directly from the
initial site assessment to full scale site characterization. As program
implementors and facility owners/operators have gained experience in
corrective action implementation, they have often found it advantageous
to conduct a limited release assessment after the RFA but before full
scale site characterization, to focus subsequent investigations or
eliminate certain units or areas from further consideration. Release
assessments can be especially helpful in cases where the RFA is old or
where the overseeing agency and the facility owner/operator disagree
about inclusion of one or more units, areas, or releases in the site
characterization.
Information collected during a release assessment can be used to
focus site characterizations on the areas and releases and exposure
pathways which constitute the greatest risks or potential risks to
human health and the environment and to eliminate areas from
consideration during site characterization. For example, an initial
site assessment could identify an old waste pile as a solid waste
management unit. The facility owner/operator might present information
showing that the waste in the pile had been removed; however, there may
be little or no information to confirm that releases from the unit (if
any) were adequately addressed during waste removal. The facility
owner/operator could, during a release assessment, conduct highly
focused sampling at the unit to confirm that releases either had not
occurred or were adequately remediated.
c. National Corrective Action Prioritization System. Implementing
agencies often use initial site assessments to set priorities for
limited oversight resources. In the corrective action program, EPA sets
priorities using the National Corrective Action Prioritization System
(NCAPS). NCAPS priorities are generally based on information gathered
during the RFA. Because of the number of facilities subject to
corrective action, the variety of facility-specific conditions, and the
limitations on Agency oversight resources, careful prioritization is
essential. The Agency's policy is to focus its corrective action
resources first on facilities and areas at facilities which present the
greatest relative risk to human health and the environment.
Accordingly, NCAPS considers the environmental setting of a facility
and potential receptors, actual and potential releases of hazardous
wastes or constituents from the facility, and the toxicity of
constituents of concern to group facilities into high, medium and low
priority groups.
NCAPS rankings are based on risk, but NCAPS does not involve a
traditional site-specific risk assessment. NCAPS is a resource
management tool that EPA and authorized states use to set relative
priorities among corrective action sites to focus limited agency
resources. Currently 40% of facilities subject to corrective action are
considered high priority, 30% medium, and 30% low.
2. Site Characterization
Before cleanup decisions can be made, some level of
characterization is necessary to ascertain the nature and extent of
contamination at a site and to gather information necessary to support
selection and implementation of appropriate remedies. In the CERCLA
program, this step is referred to as the Remedial Investigation or RI;
in the RCRA program, the RCRA Facility Investigation or RFI.
Carefully designed and implemented RFIs are critical to accurately
characterize the nature, extent, direction, rate, movement, and
concentration of releases at a given facility; this information is
needed to determine potential risks to human health and the environment
and support development and to implementation of corrective measures
should they prove necessary. It can also be used to eliminate
facilities which are shown not to present unacceptable risks from
further consideration. A successful RFI will identify the presence,
movement, fate, and risks associated with environmental contamination
at a site and will elucidate the chemical and physical properties of
the site likely to influence contamination migration and cleanup.
The 1990 proposal outlines the types of information which may be
required during a remedial investigation. As discussed in the 1990
proposal, program implementors and facility owners/operators should
gather the information necessary to support cleanup decisions;
collection of all the information discussed in the 1990 proposal will
not be necessary at most facilities.
Experience in corrective action implementation has demonstrated
that poorly focused investigations can become a drain on time and
resources and, in some cases, unnecessarily delay remedial actions. EPA
emphasizes that remedial investigations should be tailored to the
specific conditions and circumstances at the facility and focused on
the units, releases, and exposure pathways of concern. For example, in
delineating the extent of contamination it may not be necessary to
delineate to background concentrations in all cases. In some cases,
information adequate to support cleanup decisions can be obtained
through delineation to risk-based concentrations or other investigation
endpoints. For example, an investigation endpoint might be based on the
presence or absence of a competent confining layer rather than
constituent concentrations.
EPA has found a number of approaches to be particularly helpful in
developing focused site investigations, as discussed below.
a. Conceptual Site Models. Site investigations and remedy
implementation are often most successful when based on a ``conceptual
site model.'' A conceptual site model is a three-dimensional picture of
site conditions that conveys what is known or suspected about the
sources, releases and release mechanisms, contaminant fate and
transport, exposure pathways and potential receptors, and risks. The
conceptual site model is based on the information available at any
given time and will evolve as more information becomes available. The
conceptual site model may be used to present hypotheses that additional
investigations could confirm or refute, to support risk-based decision-
making, and to aid in identification and design of potential remedial
alternatives.
The conceptual site model is not a mathematical or computer model,
although these tools often prove helpful in visualizing current
information and predicting future conditions. The conceptual site model
can be
[[Page 19445]]
documented by written descriptions of site conditions and supported by
maps, cross sections, analytic data, diagrams of the site that
illustrate actual or potential receptors, and other descriptive tools.
The conceptual site model is dynamic and should be tested and
refined from the very first stages of corrective action to the point at
which the site has been remediated and no longer presents a threat to
human health or the environment. The RCRA Facility Assessment often
forms the basis for the first conceptual model of the site. At this
stage, the model should be used as a tool to compile available and
relevant information and to identify the urgency and scope of
subsequent investigations as well as interim actions. One use of the
conceptual site model could be to ensure that site conditions are
consistent with the underlying assumptions that were used to develop
standardized action levels (see Section III.C.2.e). The model can also
be used to support phasing of site investigations to ensure data
collection efforts address the most important information needs. In
addition, a conceptual site model can be a critical tool for evaluating
remedy performance.
More detailed guidance on the development and use of the conceptual
site model is available in ``Guidance for Evaluating the Technical
Impracticability of Ground Water Restoration'' (EPA/540-R-93-080).
Additional guidance on using conceptual models will be included in the
upcoming Soil Screening Guidance (see, Section II.F.6.b).
b. Innovative Site Characterization Technologies. In the 1990
proposal, EPA recommended a focused approach to site characterization
activities. EPA continues to support data collection approaches that
focus on information needed to support decisions. The Agency has seen
tremendous improvements in site characterization efficiency when
innovative approaches are used, especially those that rely on rapid
sample collection (e.g., direct-push technologies) and on-site
analytical techniques (e.g., sensor technologies, assay kits, field gas
chromatography/mass spectrometry (GC/MS), X-ray fluorescence).
Depending on the data quality objectives for a particular site,
confirmatory laboratory analyses may also be necessary. Data quality
objectives are discussed in Section III.C.2.c, below.
The benefits of using innovative site characterization technologies
are magnified when a work plan is used only to convey strategies,
methods, data quality objectives, and general areas subject to
investigation, and exact sample locations are left to be determined
based on iterative on-site data collection and analysis. Some of the
benefits of using innovative characterization techniques along with
iterative decision-making include: Rapid sample collection and analysis
allowing for on-site decision making and optimization of the
investigation effort; enhanced three-dimensional understanding of the
site because of the greater number of data points available for a given
commitment of resources; better identification of actual or potential
risks to human health and environmental receptors; and, more rapid
assessment of the need for interim actions.
Program implementors and facility owners/operators should take
advantage of innovative characterization technologies. Likewise, EPA
encourages implementing officials to be receptive to innovative
approaches which can significantly improve the quality as well as the
cost- and time-effectiveness of site characterization.
c. Tailored Data Quality Objectives. Program implementors and
facility owners/operators should tailor data gathering strategies to
the purpose for which the data will be used. The overall degree of data
quality or uncertainty that a decision maker is willing to accept is
referred to as the Data Quality Objective (DQO) for a decision. The DQO
is used to specify the quality of the data, usually in terms of
precision, bias, representativeness, comparability and completeness.
The DQO approach applies to the entire measurement system (e.g.,
sampling locations, methods of collection and handling, field analysis,
etc.), not just to laboratory analytical operations. In general, EPA
has found that DQOs can and should be used to ensure that environmental
data are scientifically valid, defensible, and of an appropriate level
of quality given the intended use for the data.
Program implementors and facility owners/operators using innovative
site characterization and assessment approaches should pay particular
attention to DQOs. For example, an objective of the early stages of an
investigation could be to identify the presence of gross contamination.
In this context, a DQO could include a higher method detection limit
(e.g., part per million) that could be obtained with cost-effective
field screening technologies. In contrast, a very low method detection
limit (part per billion or even trillion) could be an appropriate DQO
to determine if groundwater is fit for human consumption.
EPA encourages program implementors and facility owners/operators
to use the DQO approach to define adequate data collection for
corrective action decisions. EPA has found that site investigations can
be expedited considerably when DQOs are carefully established. For
additional information on incorporating DQOs in the decision-making
process at RCRA facilities, see Chapter One of SW-846 (Chapter One of
SW-846, Test Methods for Evaluating Solid Waste, Physical/Chemical
Methods, Third Edition as amended by Update I, July 1992); ``Final
Guidance for the Data Quality Objective Process'' EPA QA/G-4, September
1994; and, ``Quality Assurance Project Plans for RCRA Ground-Water
Monitoring and Corrective Action Activities'' EPA, Sylvia Lowrance and
H. Matthew Bills, July 1993, available in the docket for today's
Notice.
d. Use of Existing Information to Streamline the Remedial
Investigation. Many RCRA facility owners/operators have collected
information on physical characteristics or on the nature and extent of
contamination at the facility outside of the RCRA corrective action
process. Information on site conditions may have also been obtained by
entities other than the facility owner/operator. As a general
principle, information that is not time dependent should not be
collected again; EPA encourages the incorporation of pertinent existing
information into the corrective action process. For example, many
states have required facilities to conduct groundwater investigations
under state laws for units that are not regulated units under RCRA;
this information can often be easily incorporated into a corrective
action investigation. Similarly, information collected through a state
Superfund process is also generally of appropriate quality to be
directly useable to support corrective action decisions.
Information that is relevant to corrective action may exist in
reports or formats that are not traditionally used for RCRA corrective
action. For example, engineering boring logs may have been generated on
the facility by local utility companies, or by the facility itself
during building construction. Provided data and information are
submitted in a usable format, state or Federal agencies overseeing RCRA
corrective actions should not require adequate information to be
recollected or reformatted.
Facility owners/operators who are developing site characterization
or other information independently are urged to document the quality of
their information carefully. Thorough
[[Page 19446]]
documentation of data quality will increase its usefulness in the
corrective action process. Use of existing information can reduce costs
of conducting investigations and increase the speed of corrective
action cleanups.
To determine whether existing data is appropriate for corrective
action decisions, the nature and quality of the information should be
assessed in view of the goals of the corrective action investigation.
Where DQOs have been established, existing data can be assessed against
DQOs to determine their adequacy. For example, the DQO for a specific
corrective action decision could be a minimum analytical detection
limit that is considerably lower than that used in an existing study.
In this case, non-detects in the existing data could not be used to
justify no action; however, the existing data could be used to
determine ``hot-spots'' and to plan a second phase study using a more
sensitive analytical method. On the other hand, if the detection limits
were below an acceptable risk level and no constituents were detected,
re-sampling would not typically be required--even if more sensitive
methods were available.
EPA regions and states are currently incorporating existing
information into ongoing corrective actions. If the regulatory agencies
are aware of pertinent existing information at the time of issuance of
a permit or order, they have the option of explicitly referencing the
relevant information in the facility investigation requirements of the
permit or order or, if the data are of sufficient quality and quantity,
stating that the data fulfill site investigation needs. In some cases,
the facility owner/operator will inform the overseeing agency of
existing information; EPA or the states have the option of redirecting
any investigations based upon the relevance of this information.
e. Role of Action Levels. At certain facilities subject to
corrective action, contamination will be present at concentrations that
may not justify further action. For this reason, EPA has, in some
cases, used the concept of ``action levels'' as a trigger mechanism for
conducting additional corrective action activities (e.g., additional
investigations, evaluation of remedial alternatives, site-specific risk
assessments). Under this approach, contamination found in a particular
medium below an appropriate action level would not generally be subject
to remediation or further study.
Action levels are health- or environmental-based concentrations
derived using chemical-specific toxicity information and standardized
exposure assumptions. Action levels are often established at the more
protective end of the risk range (e.g., 10-6) using conservative
exposure and land use assumptions; however, action levels based on less
conservative assumptions could be appropriate based on site-specific
conditions. For example, if the current and reasonably anticipated
future uses of a site are industrial, an action level based on
industrial exposure scenarios could be appropriate.
Action levels can be developed on a facility-specific basis or can
be taken from standardized lists. Currently, some states and EPA
Regions have developed standardized lists of action levels or cleanup
levels (standardized cleanup levels can serve as action levels) for
RCRA corrective action facilities and other cleanup sites. One of the
earlier and more widely distributed lists of action levels was
developed by EPA and included in Appendix A of the preamble to the 1990
proposal. Since 1990, toxicity research has progressed; accordingly,
some of the action levels included in the 1990 proposal may no longer
be appropriate. In addition, the action levels in the 1990 proposal
were based on residential land-use assumptions which may not be
appropriate at all corrective action facilities. Program implementors
and facility owners/operators should ensure that action levels used at
RCRA corrective action facilities reflect up-to-date toxicity
information and that action level assumptions are consistent with the
physical conditions and current or reasonably anticipated exposure
assumptions at any given facility. For example, risk to ecologic
receptors is not accounted for in the action levels included in the
1990 proposal. If ecologic risks are a concern at a given corrective
action facility, program implementors and facility owners/operators
should consider developing facility-specific action levels to account
for ecologic risk issues.
EPA has found that action levels are most beneficial when they are
available during the planning stages of site investigations. In the
1990 proposal, the Agency indicated that it would be advantageous to
include action levels in corrective action permits to give facility
owners/operators and the public an indication of contaminant
concentrations that would likely trigger additional study or corrective
measures. At the same time, the Agency recognized that, in some cases,
including action levels in corrective action permits would not be
necessary (e.g., when available information establishes the need for an
analysis of remedial alternatives). Program implementors and facility
owners/operators have the flexibility to determine whether or not to
include action levels in corrective action permits and orders.
In Section V of today's Notice, EPA requests comments on the use of
action levels and the role of the Federal government in promoting
national consistency by developing, maintaining, and distributing
action levels (as well as media cleanup levels) or standardized
protocols for developing site-specific levels.
f. Integration With the Evaluation of Remedial Alternatives. At
most sites, likely remedial strategies will become clear during the
initial site assessment and subsequent site characterization. To
expedite the corrective action process, EPA encourages program
implementors and facility owners/operators to focus data gathering
during site characterization on information needed to support plausible
remedies. This strategy is discussed more fully in Section III.C.4.a of
today's Notice.
3. Interim Actions
Since the 1990 proposal, EPA has increasingly emphasized the
importance of interim actions and site stabilization in the corrective
action program. Many cleanup programs, including RCRA and CERCLA,
recognize the need for interim actions while site characterization is
underway or before a final remedy is selected. Typically, interim
actions are used to control or abate ongoing risks to human health or
the environment in advance of final remedy selection. For example,
actual or potential contamination of drinking water supplies might
necessitate an interim action to provide alternative drinking water
sources. Similarly, hazardous waste or constituents stored in poorly
maintained or damaged drums or tanks might require an interim action to
stabilize (e.g., by overpacking) or remove the damaged containers. The
concept of interim actions is especially appropriate to facilities
subject to RCRA corrective action, since many facilities in the
corrective action universe are operating industrial facilities, where a
final facility cleanup might not be completed for many years.
One of EPA's overriding goals in managing the corrective action
program is to expedite risk reduction by emphasizing early
implementation of interim actions to control or minimize ongoing
threats to human health or the environment. The importance of interim
actions at RCRA corrective action facilities is further emphasized in
the Agency's Stabilization Initiative
[[Page 19447]]
discussed in Section II.E.1 of today's Notice.
Interim actions at RCRA facilities can include a wide range of
activities such as source removal, installation of a pump and treat
system, and institutional controls. In accordance with the
Stabilization Initiative, interim actions should be employed as early
in the corrective action process as possible, consistent with the
environmental objective and priorities for the site; as further
information is collected, program implementors and facility owners/
operators should continue to look for opportunities to conduct
additional interim actions. Generally, interim actions should be
compatible with, or a component of, the final remedy.
4. Evaluation of Remedial Alternatives
Contamination at most cleanup sites can be addressed using a number
of remedial alternatives, each of which would present advantages and
disadvantages. Before choosing a cleanup approach, program implementors
and facility owners/operators will typically analyze a range of
alternatives and evaluate their advantages and disadvantages relative
to site-specific conditions. In the CERCLA program the identification
and evaluation of remedial alternatives is referred to as the
Feasibility Study or FS; in the RCRA corrective action program, the
Corrective Measures Study or CMS.
The purpose of a Corrective Measures Study is to identify and
evaluate potential remedial alternatives for facilities undergoing
corrective action. During the CMS, program implementors and facility
owners/operators typically evaluate one or more remedial alternatives
based on site-specific conditions and select a preferred remedial
alternative as the remedy. The CMS does not necessarily have to address
all potential remedies for every corrective action facility. EPA
advises program implementors and facility owners/operators to focus
corrective measures studies on realistic remedies and to tailor the
scope and substance of studies to the extent, nature and complexity of
releases and contamination at any given facility. For example, some
potential remedies should not be considered because they are simply
implausible. In cases where EPA has identified a presumptive remedy
(presumptive remedies are discussed in Section II.F.6.c of today's
Notice), the purpose of the CMS will be to confirm that the presumptive
remedy is appropriate to facility-specific conditions. In cases where
EPA or a state is using performance standards or a similar approach,
the Agency might not require submission or approval of a formal CMS at
all. EPA continues to emphasize that it does not want studies to be
undertaken simply for the purpose of completing a perceived step in a
perceived process. While, for a complex site, review of a full range of
remedial alternatives may be required, at many sites, the preferred
remedial approach will be apparent early in the cleanup process and the
analysis of remedial alternatives should be highly focused.
In implementing the corrective action program, EPA has found a
number of opportunities to significantly increase the efficiency of
corrective measures studies, as discussed below.
a. Integration With Site Characterization. EPA continues to
emphasize that the components of corrective action (e.g., release
assessment, RFI, CMS) should not be viewed as isolated steps in a
linear process. In the Agency's experience, it is generally more
efficient to focus data collection on information needed to support an
appropriate, implementable remedy than to attempt to complete separate
evaluations at each step. As remedial alternatives are considered
during a CMS, the facility owner/operator might find additional site
characterization necessary. Similarly, the earlier in the corrective
action process potential remedies can be identified, the more
effectively information gathering can be focused. For example, in a
situation where the contamination being addressed involves a large
mixed fill landfill, the remedial alternatives will likely involve
physical and institutional controls. These alternatives should be
identified early in the RFI enabling the facility owner/operator to
tailor the RFI toward collection of information necessary to support
development of appropriate physical controls. In other cases, a
facility may have relatively limited soil contamination or old solid
waste management units which the facility owner/operator desires to
remove all contaminated material for treatment and disposal off-site.
In these cases, the RFI might be focused on removal options and
analysis of other alternatives would not be necessary. Other benefits
associated with combination of the RFI and CMS can include cost savings
associated with consolidation of reports and other documents, and time
savings associated with concurrent rather than sequential analysis. The
1990 proposal and the 1990 RCRA Corrective Action Plan discuss other
situations where the CMS could be combined with site characterization,
including:
(1) ``Low risk'' facilities. These are facilities where
environmental problems are relatively small and where releases present
minimal exposure concerns. Such facilities might have limited on-site
soil contamination;
(2) Facilities where removal remedies have been proposed by the
owner/operator. For example, at a facility where there is contaminated
soil and the owner/operator proposes to excavate all the contaminated
soil for subsequent off-site recycling, treatment or disposal;
(3) Facilities with straightforward remedial solutions or where
presumptive remedies, as discussed in Section II.F.6.c of today's
Notice, can be applied. These are facilities where standard engineering
solutions, which have proven effective in similar situations, may be
appropriately applied;
(4) Facilities where few remedial options are available. This
includes situations where there are few practicable remedial solutions;
and,
(5) Facilities where the remedy is phased.
b. Formal Evaluation Not Always Necessary. At some facilities the
CMS does not have to be submitted to an overseeing agency for review
and approval in favor of a performance-based approach. In these
scenarios, the overseeing agency (e.g., EPA or a state) might oversee
the facility investigation to ensure that all releases and potential
releases from the facility are adequately identified and characterized
and that adequate remedial goals are developed for the facility. After
the remedial goals undergo public review and comment and are approved
by the overseeing agency, the facility owner/operator would design and
implement a remedy sufficient to meet the remedial goals without direct
agency oversight.
For example, the remedial investigation at a facility may reveal
widespread groundwater contamination caused by a release from an old
surface impoundment. The remedial goals for the facility might be to
control the source contaminating the groundwater, contain the
groundwater plume, and restore groundwater quality to specified cleanup
levels. Media cleanup levels would be included in the remedial goal and
the facility owner/operator would be required to conduct remedial
activities in a manner which involves the affected public in a
meaningful and timely way. The facility owner/operator would then
design and implement a remedy (and a public participation plan). In
this example, while the facility owner/operator might analyze a number
of alternatives, the overseeing agency would not ordinarily second-
guess the
[[Page 19448]]
remedial choice (since the agency had been involved in developing the
performance standards). Instead, the overseeing agency would monitor
compliance with the remedial goals. If the remedial goals or milestones
were not met in the required performance period, additional remediation
measures would likely be required. EPA favors performance-based
approaches provided that the remedial goals for the facility are clear,
the oversight during remedy implementation is appropriate to the
complexity of the facility-specific circumstances, and the public is
substantively involved. Many states, in particular the State of
Georgia, attribute the success of their corrective action programs, in
part, to eliminating Agency review and approval of the CMS as a step in
the corrective action process in favor of a performance-based approach.
c. Facility Owner/Operator Should Recommend a Preferred Remedy. EPA
emphasizes that it expects facility owners/operators to develop and
recommend remedies or remedy performance standards (if a performance-
based model is being used), including proposed media cleanup levels,
points of compliance and compliance time frames, that address the
proposed threshold criteria and present an advantageous combination of
the proposed balancing criteria. During remedy selection, EPA will
consider the facility owner/operator's preferred remedial alternative,
other remedial alternatives and public comment. Although it is the
responsibility of the facility owner/operator to develop and recommend
a preferred remedial alternative or remedy performance standard, the
Agency can reject any alternative and require further analysis or
prescribe a different remedial alternative or remedy performance
standard.
5. Remedy Selection
Remedies should be protective of human health and the environment,
and maintain protection over time. In meeting this remedial goal, EPA
has learned that certain combinations of facility-specific
circumstances are often addressed by similar approaches. Based on this
experience, the Agency has developed certain expectations for remedies.
Remedy expectations are not binding requirements; rather, they reflect
collective experience and guide development of remedial alternatives.
For example, the fact that remedies for highly mobile contaminants
often involve some form of treatment does not preclude a non-treatment
option; however, expectations developed from past experience can focus
program implementors and facility owners/operators on the more
generally acceptable remedial options. In effect, the remedial
expectations allow program implementors and facility owners/operators
to profit from prior EPA experience and focus resources on the most
plausible remedial alternatives. Many of these expectations were first
articulated in the discussion of remedy selection at CERCLA sites in
the National Oil and Hazardous Substances Pollution Contingency Plan
(NCP) (40 CFR 430(a)(1)). The remedial expectations discussed below
express EPA's experiences to date given our current remedial goals and
remedy selection strategies; however, the Agency recognizes that issues
associated with remedial goals and strategies are currently the subject
of considerable public debate, i.e., in Congressional discussions of
Superfund reauthorization. Since EPA is committed to consistency of
results between the RCRA corrective action and Superfund remedial
programs, any revisions to the CERCLA remedial expectations or the
CERCLA remedy selection process will likely be incorporated into RCRA
corrective action. Currently, EPA has the following remedial
expectations:
(a) EPA expects to use treatment to address the principal threats
posed by a site whenever practicable and cost-effective.5
Contamination that represents principal threats for which treatment is
most likely to be appropriate includes contamination that is highly
toxic, highly mobile, or cannot be reliably contained, and that would
present a significant risk to human health and the environment should
exposure occur.
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\5\ The term ``cost-effective'' does not necessarily imply least
costly.
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(b) EPA expects to use engineering controls, such as containment,
for wastes and contaminated media which can be reliably contained, pose
relatively low long-term threats, or for which treatment is
impracticable.
(c) EPA expects to use a combination of methods (e.g., treatment,
engineering and institutional controls), as appropriate, to achieve
protection of human health and the environment.
(d) EPA expects to use institutional controls such as water and
land use restrictions primarily to supplement engineering controls as
appropriate for short- and long-term management to prevent or limit
exposure to hazardous wastes and constituents. EPA does not expect that
institutional controls will often be the sole remedial action.
(e) EPA expects to consider using innovative technology when such
technology offers the potential for comparable or superior treatment
performance or implementability, less adverse impact, or lower costs
for acceptable levels of performance when compared to more conventional
technologies.
(f) EPA expects to return usable groundwaters to their maximum
beneficial uses wherever practicable, within a time frame that is
reasonable given the particular circumstances of the site. When
restoration of groundwater is not practicable, EPA expects to prevent
or minimize further migration of the plume, prevent exposure to the
contaminated groundwater and evaluate further risk reduction. EPA also
expects to control or eliminate surface and subsurface sources of
groundwater contamination.
(g) EPA expects to remediate contaminated soils as necessary to
prevent or limit direct exposure of human and environmental receptors
and prevent the transfer of unacceptable concentrations of contaminants
(e.g., via leaching, runoff or air borne emissions) from soils,
including subsurface soils, to other media.
In addition to experiences recorded in the remedial expectations,
EPA routinely encounters a number of issues associated with remedy
selection, as discussed below.
a. Balancing Treatment and Exposure Control. Risk is a function of
toxicity and exposure; therefore, risk reduction can be accomplished by
reducing toxicity (e.g., through treatment to reduce toxicity, mobility
or volume) and/or preventing exposure (e.g., through engineering and
institutional controls). Program implementors and facility owners/
operators often struggle to find an appropriate balance between these
approaches.
While preventing exposure may appear to be the most direct near-
term means of reducing risk, permanent reduction of the toxicity,
mobility and/or volume of contaminated material might be the most cost-
effective means of reducing risk over time. For example, at a facility
where the remedy relies, in part, on engineering controls to prevent
exposure there could be: associated operation and maintenance costs;
the need to maintain the RCRA facility permit for the life of the
remedy; increased Agency involvement to monitor the continued
effectiveness of the remedy; and, need for institutional controls. When
treatment to reduce toxicity, mobility or volume is chosen, EPA does
not necessarily expect the remedy to involve treatment alone. For
[[Page 19449]]
example, highly toxic contaminated material could be treated so that
the concentrations of hazardous constituents, while still above media
cleanup levels, would support a reliable containment remedy.
The exact balance between reduction in toxicity, mobility or volume
and exposure control will best be established on a case-by-case basis
in consideration of site-specific conditions; however, all things being
equal, permanent reductions in toxicity, mobility or volume are
preferred to exposure control because it is protective of human health
and the environment in the long-term and removes the risks associated
with the potential failure of engineering or institutional controls.
Program implementors and facility owners/operators are cautioned
against too great a reliance on exposure control remedies when
alternatives which include permanent reduction in toxicity, mobility or
volume are available, affordable and practical. Additional information
on the balance between toxicity reduction and exposure control is
available in ``A Guide to Principal Threat and Low Level Threat
Wastes,'' Superfund Publication 9380.3-06FS, November 1991, which is
available in the docket for today's Notice.
b. Remedy Selection Criteria. The 1990 proposal, like the Superfund
NCP, established a two-phased evaluation for remedy selection. During
the first phase, potential remedies are screened to see if they meet
``threshold criteria''; remedies which meet the threshold criteria are
then evaluated using various ``balancing criteria'' to identify the
remedy that provides the best relative combination of attributes. While
the CERCLA remedy selection criteria are not identical to the RCRA
corrective action criteria proposed in 1990, they address the same
types of considerations and should generally result in similar remedies
when applied to similar site-specific conditions.
The 1990 proposal identified four remedy threshold criteria and
five balancing criteria. The four threshold criteria proposed in 1990
were that all remedies must: (1) be protective of human health and the
environment; (2) attain media cleanup standards; (3) control the
source(s) of releases so as to reduce or eliminate, to the extent
practicable, further releases of hazardous waste (including hazardous
constituents) that might pose threats to human health and the
environment; and (4) comply with applicable standards for waste
management. EPA believes these threshold criteria remain appropriate as
general goals for cleanup and screening tools for potential remedies.
There has been some confusion regarding the proposed threshold
criterion that remedies attain media cleanup standards. Attaining media
cleanup standards does not necessarily entail removal or treatment of
all contaminated material above specific constituent concentrations.
Depending on the site-specific circumstances, remedies may attain media
cleanup standards through various combinations of removal, treatment,
engineering and institutional controls. For example, in situations
where waste is left in place in an engineered landfill or under a cap,
media cleanup standards would be attained, in part, through long-term
engineering and institutional controls.
The 1990 proposal identified five balancing criteria for choosing
among remedies that meet the threshold criteria. The five balancing
criteria proposed in 1990 were: (1) Long-term reliability and
effectiveness; (2) reduction of toxicity, mobility or volume of wastes;
(3) short-term effectiveness; (4) implementability; and (5) cost. The
balancing criteria were not ranked in terms of relative importance. As
discussed in the 1990 proposal, any one of the balancing criteria might
prove to be the most important at a particular site. For example, a
remedy at a certain site might be protective in the short term but not
necessarily reliable in the long term (e.g., capping of a highly
contaminated area). In this case, the need for long term reliability
and the potential for long-term operation and maintenance costs would
tend to point toward a remedy which presented a more advantageous
combination of the balancing criteria (e.g., removal or treatment of
hot spots, capping residual contamination, and implementing an
institutional control).
The proposed balancing criterion of cost has caused some confusion.
Cost can and should be considered when choosing among remedies which
meet the threshold criteria. As discussed in the 1990 proposal, EPA
believes that many potential remedies will meet all the threshold
criteria. In that situation, cost becomes an important consideration in
choosing the remedy which most appropriately addresses the
circumstances at the facility and provides the most efficient use of
Agency and facility owner/operator resources. For cost comparisons
between alternatives to be accurate, they should include capital and
operation and maintenance costs for the anticipated life of the remedy.
Pending resolution of the 1990 proposal, program implementors and
facility owners/operators should use the threshold and balancing
criteria proposed in 1990 as guidance when selecting facility-specific
remedies; however, as discussed in Section V of today's Notice, EPA is
also considering and requesting comment on a number of alternatives for
corrective action remedy selection, including focusing on remedy
performance standards. These alternatives are based, in part, on
innovative approaches already used in some states and EPA Regions.
c. Media Cleanup Standards. The term ``media cleanup standards''
typically refers to broad cleanup objectives; it often includes the
more specific concepts of ``media cleanup levels,'' ``points of
compliance,'' and ``compliance time frames.'' The more specific term,
``media cleanup levels'' typically refers to site- and media-specific
concentrations of hazardous constituents, developed as part of the
overall cleanup standards for a facility. Media cleanup standards (and
levels) should reflect the potential risks of the facility and media in
question by considering the toxicity of the constituents of concern,
exposure pathways, and fate and transport characteristics.
Consistent with the CERCLA program, in the RCRA corrective action
program EPA intends to clean up sites in a manner consistent with
available, protective, risk-based media cleanup standards (e.g., MCLs
and state cleanup standards) or, when such standards do not exist, to
clean up to protective media cleanup standards developed for the site
in question (e.g., through a site-specific risk assessment). Both
approaches require a site-specific risk-based decision. When available
media cleanup standards are used (e.g., MCLs, state cleanup standards),
the assumptions used to develop the standardized cleanup values should
be consistent with the site-specific conditions at the facility in
question.
As discussed in the NCP and the 1990 proposal, EPA's risk reduction
goal is to reduce the threat from carcinogenic contaminants such that,
for any medium, the excess risk of cancer to an individual exposed over
a lifetime generally falls within a range from 10-6, in other
words, an exposed individual will have an estimated upperbound excess
probability of developing cancer of one in one-million, to 10-4,
or an exposed individual will have an estimated upperbound excess
probability of developing cancer of one in ten-thousand. For non-
carcinogens, the hazard index should generally not
[[Page 19450]]
exceed one (1).6 Available risk-based media cleanup standards are
considered protective if they achieve a level of risk which falls
within the 10-6 to 10-4 risk range.
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\6\ The hazard index is a measurement of non-carcinogenic risks.
It is calculated by summing two or more hazard quotients for
multiple substances and/or multiple exposure pathways. A hazard
quotient is the ratio of a single substance exposure level over a
specified time period to a reference dose for that substance derived
from a similar exposure period.
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EPA's preference, all things being equal, is to select remedies
that are at the more protective end of the risk range. Therefore,
program implementors and facility owners/operators should generally use
10-6 as a point of departure when developing site-specific media
cleanup standards. Use of 10-6 as a point of departure does not
establish a strict presumption that all final cleanups will necessarily
attain that level of risk reduction. Given the diversity of the
corrective action universe and the emphasis on consideration of site-
specific conditions such as exposure, uncertainty, or technical
limitations, the Agency expects that other risk reduction goals may be
appropriate at many corrective action facilities. As discussed in the
1990 proposal, EPA endorses ``* * * an approach [to remedy selection]
that allows a pragmatic and flexible evaluation of potential remedies
at a facility while still protecting human health and the environment.
This approach emphasizes the overall goal of 10-6 as the point of
departure, while allowing site or remedy-specific factors, including
reasonable foreseeable future uses, to enter into the evaluation of
what is appropriate at a given site.'' (See, 55 FR 30826.)
d. Points of Compliance. As proposed in 1990, the point of
compliance (POC) is the location or locations at which media cleanup
levels are achieved. In the absence of final corrective action
regulations specifically addressing points of compliance, program
implementors and facility owners/operators develop POCs on a site-
specific basis. For air releases, program implementors and facility
owners/operators have generally used the location of the person most
exposed, or other specified point(s) of exposure closer to the source
of the release. For surface water, program implementors and facility
owners/operators have routinely established the POC at the point at
which releases could enter the surface water body; if sediments are
affected by releases to surface water, a sediment POC is also
established. Points of compliance for soils are generally selected to
ensure protection of human and environmental receptors against direct
exposure and to take into account protection of other media from cross-
media transfer (e.g., via leaching, runoff or airborne emissions) of
contaminants. For groundwater, program implementors and facility
owners/operators generally set the POC throughout the area of
contaminated groundwater or, when waste is left in place, at and beyond
the boundary of the waste management area encompassing the original
source(s) of groundwater contamination. This approach to the
groundwater POC is generally referred to as the ``throughout the plume/
unit boundary POC.'' This approach is consistent with the groundwater
POC described in the preamble to the Superfund program's National Oil
and Hazardous Waste Contingency Plan (NCP, pages 8713 and 8753, Federal
Register March 8, 1990). EPA recommends consideration of the following
factors when developing a site-specific groundwater POC: proximity of
sources of contamination; technical practicability of groundwater
remediation; vulnerability of the groundwater and its possible uses;
and, exposure and likelihood of exposure and similar considerations.
In 1990, EPA proposed specific POCs for groundwater, air, surface
water, and soil. These proposals, especially the proposed POC for
groundwater, generated a substantial number of comments. Developing
site-specific points of compliance generally continues to be an area of
discussion and debate. In Section V.E.2 of today's Notice, EPA requests
additional comment regarding POCs for corrective action.
e. Compliance Time Frame. The compliance time frame is the time
period and schedule according to which corrective actions are
implemented. In the 1990 proposal, EPA expressed a preference for the
expeditious stabilization of releases, followed by timely completion of
corrective actions and full restoration of contaminated media; however,
a number of factors may influence the time frame within which media
cleanup standards are attained, including: the extent and nature of
contamination at the facility; risks to human health and the
environment before and during remedy implementation; practical
capabilities of remedial technologies; the availability of treatment or
disposal options; and, the desirability of utilizing emerging
technologies.
Remedy implementation schedules developed at the time of remedy
selection should, to the extent possible, specify the compliance time
frame; however EPA recognizes that uncertainties associated with
remediation may make it impossible to specify when a remedy must be
completed. For example, due to complexities associated with contaminant
occurrence in the subsurface and with groundwater remediation in
general, the time needed to remediate groundwater at some sites cannot
be accurately predicted. In these circumstances, the Agency recommends
the use of performance measures or milestones monitored over time to
track progress toward attaining remedial goals. These performance
measures should be specified in the remedy implementation plans or
performance standards. In cases where it is not practical to determine
a precise compliance time frame, estimated compliance time frames may
be used to help evaluate remedial alternatives and the technical
practicability of site-specific remedial goals.
EPA emphasizes that, at many sites, the primary focus should be on
near-term stabilization of releases. At these sites, it may be
appropriate to focus the compliance time frame and corrective measures
implementation schedule on the stabilization action; the remaining
compliance time frame and corrective measures implementation schedule
(if any are necessary) could then be developed during selection of the
facility-wide remedy.
f. Site-Specific Risk Assessments. EPA's strategy for corrective
action implementation incorporates risk-based decision-making
throughout the corrective action process. At some sites, risk-based
decisions can be made using standardized risk considerations, such as
standardized exposure assumptions. At other sites, a site-specific risk
assessment will be desirable. When a site-specific risk assessment is
needed, EPA, in some cases, has directed the facility owner/operator to
perform the risk assessment; in other cases EPA has chosen to do the
risk assessment itself based on data submitted by the owner/operator.
Site-specific risk assessments conducted at RCRA facilities may be
based on CERCLA's extensive guidance in this area (e.g., ``Risk
Assessment Guidance for Superfund,'' Volumes I and II, Interim final
EPA/540/1-89/001 and 002, December 1989 and March 1989). Additional
information on the Agency's approach to risk-based decision-making is
available in the Agency's recent memorandum on risk characterization.
(See, 3/21/95 memorandum from Carol Browner, ``EPA Risk
Characterization Program'' in the docket for today's Notice.) The
[[Page 19451]]
Administrator stated, ``* * * we must improve the way in which we
characterize and communicate environmental (human health and ecologic)
risk.'' The key values conveyed in the 1995 Risk Characterization
guidance are: (1) ``transparency'' in the decision making process
(i.e., full and open discussion of supporting analyses, uncertainties,
assumptions, etc.); (2) ``clarity'' in communication within the Agency
and the public regarding environmental risk and the uncertainties
associated with our assessments; (3) consistency; and (4)
reasonableness in our use of scientifically defensible risk
assessments. It is EPA's policy to incorporate these values in all
risk-based considerations, including site-specific risk assessments at
corrective action facilities.
g. Ecological Risk. Corrective action remedies must protect both
human health and the environment. Some form or ecological assessment
will generally be necessary at all corrective action facilities; at
some corrective action facilities, a formal ecological risk assessment
will be necessary. When an ecological risk assessment is needed, EPA,
in some cases, has directed the facility owner/operator to perform the
risk assessment; in other cases EPA has chosen to do the risk
assessment itself based on data submitted by the owner/operator. The
use of ecological risk assessment is an important component of the
corrective action program. Often, environmental receptors are sensitive
to contamination at lower concentrations than humans are, and the
exposure is usually longer and more intense. In order to fulfill EPA's
mandate, the program must be implemented in a manner that is protective
of both human health and the environment. This includes the selection
of media cleanup standards and the implementation of remedial
activities that are protective or ecologic receptors. In the process of
selecting stabilization measures or implementing final remedies,
program implementors and facility owner/operators should be aware of
how different remedial activities may affect ecological systems,
especially sensitive populations, either on or adjacent to the
facility.
Ecological risk assessment may be even more important when non-
residential land use assumptions are used. Action or cleanup levels
based on human health exposure scenarios or land use assumptions might
not be protective of ecological receptors; therefore, consideration of
the ecological exposure pathway may, in certain settings, be the
driving factor in selection of action or cleanup levels.
CERCLA's National Contingency Plan (55 FR 8666, March 8, 1990)
designates certain key Federal agencies, state agencies and Indian
tribes as natural resource trustees. Section 300.600 of the NCP
indicates that trustees act on behalf of the public in regards to
protection of natural resources. Under CERCLA, trustees should be
notified when contamination threatens natural resources. As a matter of
policy, EPA recommends that trustees also be notified when RCRA
corrective action identifies a release that threatens natural
resources. In addition, trustee agencies have a great deal of
experience in their respective areas and can be used as a valuable
resource when conducting ecological assessments.
h. Determinations of Technical Impracticability. Remediation of
contaminated media to a desired media cleanup standard can, in certain
situations, be technically impracticable. Congress formally recognized
technical impracticability (TI) in the CERCLA statute and EPA
incorporated the concept in the National Contingency Plan and the 1990
Subpart S proposal (proposed 40 CFR 264.525(d) and 264.531).
Technical impracticability decisions may be made for any medium;
however, contaminated groundwater has received in the most TI-related
attention. The single greatest cause for technical impracticability
determinations during groundwater restoration has been the presence of
dense non-aqueous phase liquids (DNAPLs).\7\ The Superfund program
estimates that DNAPLs are likely present at approximately 60 percent of
NPL sites. While EPA has not conducted an overall assessment of the
presence of DNAPLs at RCRA facilities, it believes the percentage of
DNAPLs at high priority corrective action facilities is likely
comparable to the Superfund estimate for NPL sites. To provide a
framework for addressing technical impracticability, the Agency issued
``Guidance for Evaluating the Technical Impracticability for Ground-
Water Restoration'' (EPA/540-R-93-080). EPA encourages program
implementors and facility owner/operators to refer to this guidance for
a more detailed description of technical impracticability and a
discussion of related issues, including: a description of DNAPLs and
why they are difficult to remediate; factors to consider when making a
technical impracticability determination; and, appropriate and
practicable remedial options in situations where complete restoration
is technically impracticable.
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\7\ Liquid contaminants that do not readily dissolve in water
are known as non-aqueous phase liquids (NAPLs). NAPLs are divided
into two classes: light NAPLS (LNAPLs), such as gasoline, are less
dense than water; dense NAPLs (DNAPLs), such as the common solvent
trichloroethylene, are more dense than water. NAPLs in the
subsurface can cause long-term groundwater contamination, can be
difficult to locate and, in many circumstances, technically
impracticable to remove.
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The possibility that certain remedies may be technically
impracticable should be considered throughout the remediation process--
from the early stages of developing a conceptual site model through all
stages remedy implementation. When possible, determinations of
technical impracticability should be made early in the remediation
process and included in RCRA corrective action remedial decision
documents (permits and orders). In some cases, program implementors and
facility owner/operators might not have enough information to justify a
determination of technical impracticability at the time of the site
characterization or, even, when the remedy is selected. At the same
time, there may be strong indications that restoration of a particular
medium will be difficult and may prove technically impracticable (e.g.,
complicated groundwater remedies). In such situations, program
implementors and facility owner/operators may choose not to establish a
fixed media cleanup level, point of compliance or compliance time-
frame, since achieving full restoration may prove technically
impracticable. Instead, the remedy might proceed using interim goals
and performance measures which could be revisited as more information
became available. To avoid creating unrealistically high remedial
expectations in these situations, the corrective action permit or order
should discuss the possibility that full restoration of a particular
medium may prove technically impracticable.
By recognizing technical impracticability, EPA is not in any way
scaling back the general goal of returning contaminated groundwater to
beneficial uses. Where technical impracticability is determined, the
Agency would expect to require an alternative remedial strategy that
is: (1) technically practicable; (2) consistent with the overall
objectives of the remedy; and (3) controls the source(s) of
contamination, a
FR Doc. 96-9707 Corrective Action for Releases From Solid Waste Management Units at Hazardous Waste Management Facilities
nd human and environmental exposures. A determination
of TI does not release a facility owner/operator from corrective action
obligations.
i. Natural Attenuation. EPA's three major remedial programs (i.e.,
Superfund, RCRA Corrective Action Program, and the Underground Storage
[[Page 19452]]
Tank Program) recognize that natural attenuation, in certain
circumstances, can be an acceptable component of remedial actions for
contaminated groundwater. As discussed in the NCP, a natural
attenuation remedy uses natural processes such as biodegradation,
dispersion, dilution, and/or adsorption to achieve remedial goals.
(See, 55 FR 8734, March 8, 1990.)
Natural attenuation remedies are not ``no action'' remedies.
Natural attenuation should be evaluated, where it might be applicable,
along with and in a manner similar to other potential remedial
approaches. In some cases, natural attenuation might be only one aspect
of an overall approach to achieving remedial goals. As in any other
remedial approach, a proposed remedy involving natural attenuation will
have to be protective of human health and the environment and satisfy
remedy selection criteria. Program implementors and facility owner/
operators should provide a complete description of natural attenuation
remedies and emphasize that, by approving a natural attenuation remedy,
an overseeing agency is not allowing a responsible party to avoid its
remedial obligations. Remedies involving natural attenuation should
include: a thorough site characterization; source control or removal
where appropriate; documentation or evidence of attenuation processes
and the ability of these processes to achieve remedial objectives; an
appropriate long-term monitoring plan; and, in certain circumstances, a
contingency plan for a more active remedial measure (e.g., pumping).
j. Land Use. As discussed in the 1990 proposal, EPA's policy is
that current and reasonable expected future land use and corresponding
exposure scenarios should be considered in both the selection and
timing of remedial actions. In the 1990 proposal, the Agency stated,
``* * * contaminated soil at an industrial site might be cleaned up to
be sufficiently protective for industrial use but not residential use,
as long as there is reasonable certainty that the site would remain
industrial.'' (See, 55 FR 30803.) Recently, EPA issued additional
guidance on incorporating reasonable future land use assumptions in
remedial decision making in the guidance document ``Land Use in the
CERCLA Remedy Selection Process'' (OSWER Directive No. 9355.7-04, May
25, 1995; see Section II.F.6.a of today's Notice).
Reasonable future land use assumptions should be assessed when
developing remedial goals for any given facility and used to focus all
aspects of the corrective action process; however, EPA cautions against
automatically restricting assumptions of future land use to
extrapolation of the current use or relying only on designated zoning
or industrial use codes to establish land use assumptions. A large
industrial facility could include office areas, parking areas, a child
care area or on-site residences. Highly industrial sites are sometimes
located adjacent to residential properties. All of these factors should
be considered when making land use assumptions.
EPA recognizes the complexities associated with developing
reasonably anticipated land use assumptions and the need for caution
when basing remedial decisions on assumptions of future use; however,
the Agency believes that non-residential land use assumptions are
appropriate for many corrective action facilities. When remedies based
on non-residential exposure scenarios involve a combination of
treatment and engineering or institutional controls, program
implementors and facility owner/operators should use currently
available tools to ensure that the remedy continues to achieve its
objectives over time and the land use assumptions remain valid. For
example, many implementing agencies allow facility owner/operators to
use institutional controls to ensure that exposure scenarios at the
facility remain consistent with those used at the time of remedy
selection.
EPA requests comments on these and other land use issues in Section
V.E.1 of today's Notice.
6. Remedy Implementation
Remedy implementation typically involves detailed remedy design,
remedy construction, remedy operation and maintenance, and remedy
completion. In the CERCLA program, remedy implementation is known as
``remedial design/remedial action, operation and maintenance''; in the
corrective action program, it is known as ``corrective measures
implementation'' or CMI. As proposed in 1990, corrective measures
implementation is generally conducted in accordance with an approved
CMI plan. Components of corrective measures implementation might
include: conceptual design, operation and maintenance, intermediate
design plans and specifications, final design plans and specifications,
construction work plan, construction completion report, corrective
measure completion report, health and safety plan, public participation
plan and progress reports; however, in many cases, only a subset of
these documents will be required for individual corrective measures
implementations.
EPA has found a number of useful strategies for improving the
efficiency of corrective measures implementation, as discussed below.
a. Performance Based Corrective Measures Implementation. Similar to
the performance-based approach discussed for evaluation of remedial
alternatives in Section III.C.4.b of today's Notice, some states and
EPA regions have developed a performance-based approach to corrective
measures implementation. When using a performance-based approach to
corrective measures implementation, the overseeing agency generally
works with the facility owner/operator during remedy selection to
develop remedial goals for the facility. Following public review and
comment and approval of a remedy and remedial goals, the facility
owner/operator is tasked with designing and implementing the chosen
remedy in a manner which would meet the remedial goals. For example, if
the remedy chosen for a particular facility included some form of
groundwater treatment, an accompanying remedial goal might be to
achieve hydrologic containment of the groundwater plume and continuous
reduction of the concentrations of hazardous constituents. While the
overseeing agency would review and approve the remedy and remedial
goals and be involved in developing monitoring systems or other means
of measuring compliance with the remedial goals, it would not
necessarily be involved with the details of remedy design, construction
and implementation. Rather, the overseeing agency would monitor
compliance with the remedy implementation milestones and remedial goals
and become involved in the details of remedy design and implementation
only if a facility owner/operator was having trouble meeting the
remedial goals. A performance-based approach to remedy implementation
emphasizes that the facility owner/operator, not the overseeing agency,
is responsible for designing and implementing a successful remedy.
b. Performance Monitoring. Evaluation of the performance of a
chosen remedy is necessary to measure progress toward remedial goals
and ensure that remedial objectives are achieved. Program implementors
and facility owner/operators have recognized that appropriately
designed performance monitoring programs can maximize efficiency and
cost-effectiveness and ensure protection of potential human or ecologic
receptors.
[[Page 19453]]
Properly designed performance monitoring programs are especially
important for groundwater remediation because the concentration and
distribution of contamination in the subsurface often change with time.
Likewise, the ability of remediation systems to prevent migration of
contaminated groundwater can be influenced by natural and human factors
(e.g., seasonal precipitation or nearby agricultural groundwater
usage). For groundwater remediation systems, performance monitoring can
assess changes in subsurface conditions so that the remedy can be
modified to ensure maximum efficiency in terms of both the location and
pumping rate at individual extraction wells.
Performance monitoring is also a critical aspect of a remedial
alternative that relies on engineering controls (e.g., liners, barrier
walls). Poorly designed monitoring programs for engineered remedies can
potentially fail to detect releases from the ``contained'' areas.
While EPA recognizes the importance of performance monitoring, it
also acknowledges that long-term routines of sample collection and
analysis carry significant financial burdens. The Agency encourages
program implementors and facility owner/operators to design monitoring
programs with effectiveness and efficiency as fundamental
considerations. For example, due to subsurface heterogeneities, it may
be more effective and efficient to monitor a greater number of discrete
locations for a subset of mobile contaminants, than to monitor fewer
locations for an exhaustive list of analytical parameters and
contaminants.
Properly designed performance monitoring programs are integral to
remedy success and should be considered throughout the corrective
action process, including in remedy selection and design. Detailed
guidance regarding performance monitoring and designing monitoring
programs in general is available in ``RCRA Ground-Water Monitoring:
Draft Technical Guidance'' (EPA/530/R-93/001) and ``Methods for
Monitoring Pump-and-Treat Performance'' (EPA/600/R-94/123).
c. Completion of Corrective Measures. Documents specifying
corrective measures implementation should include methods to determine
when remedial goals have been achieved. For example, statistical
procedures are often appropriate for determining that concentrations of
hazardous constituents measured in groundwater samples meet a remedial
goal. Other remedies might require that certain tests be undertaken to
determine that engineering standards have been achieved. Decisions
regarding completion of corrective measures may be made for the entire
facility, for a portion of the facility, or for a specified unit or
release. The public and affected community should be given an
opportunity to review and comment on all proposals to complete
corrective measures.
In 1990, EPA proposed that corrective measures be considered
complete based on a three-part evaluation: the corrective measure had
to have complied with all media cleanup standards; all required source
control actions would have to be completed; and all specified
procedures for removal and decontamination of units, equipment, devices
and structures would have to be complete. In addition to certifying
compliance with the three criteria, the Agency proposed that the owner/
operator's certification be signed by an independent registered
professional ``skilled in the appropriate technical discipline(s).''
The Agency chose not to propose that all certifications be signed by an
independent qualified registered professional engineer because it
believed that engineering certifications would not be appropriate in
all cases (e.g., for a remedy largely addressing groundwater, the
Agency believed that certification by a hydrogeologist might be more
appropriate). In the absence of final regulations addressing completion
of corrective measures, program implementors and facility owner/
operators should use the requirements for completion of corrective
measures proposed in 1990 as guidance when developing site-specific
procedures for completion of corrective measures. At a minimum, the
public and affected community should be given notice and an opportunity
to comment before corrective action implementation is terminated and a
facility is released from its RCRA obligations.
D. Incorporation of Corrective Action in RCRA Permits
RCRA Section 3004(u) mandates that corrective action and schedules
of compliance be required for facilities seeking a permit, when
corrective action cannot be completed prior to permit issuance.
Approximately half the states are authorized to implement state RCRA
corrective action programs in lieu of the Federal program. In
authorized states, the state issues the RCRA permit including the
corrective action component (using any of the options discussed above).
In states not authorized for the corrective action program, the state
typically issues most of the RCRA permit and EPA issues the corrective
action portion. Although any given facility may be issued a portion of
its RCRA permit by an authorized state and a portion by EPA, this
should not lead to the perception that any given facility has more than
one RCRA permit. Program implementors and facility owner/operators
should remember that any given facility has only one RCRA permit; when
joint permitting is necessary, EPA will coordinate permitting schedules
and priorities with authorized states.
Corrective action requirements and schedules can be included in
RCRA permits in a number of ways. In some cases, the RCRA permit will
contain detailed corrective action provisions, work plan requirements,
and schedules. In other cases, the RCRA permit may incorporate
corrective action requirements by referencing another document (e.g., a
state or Federal corrective action order). Finally, in certain cases,
RCRA permits may defer to corrective action activities being conducted
under another authority or by another program. In many cases,
incorporation of corrective action requirements into any given permit
will use a combination of these strategies. For example, at a
corrective action facility where the facility owner/operator has chosen
to address a subset of the releases voluntarily, a corrective action
permit could defer action at the areas being addressed by the voluntary
cleanup while incorporating detailed corrective action conditions for
the remaining releases or areas of concern.
E. Corrective Action Orders
Although the 1990 proposal focused primarily on corrective action
under RCRA permits, EPA and the states frequently use orders to
initiate or oversee corrective actions. EPA intends for equivalent
environmental results to be achieved whether corrective action
requirements are dictated in an order or a permit. As a matter of EPA
policy, the substantive corrective action requirements and public
participation requirements imposed under either mechanism are generally
the same.
RCRA, as amended by HSWA, includes several enforcement authorities
which can be used to issue corrective action orders. The most commonly
used authority is RCRA section 3008(h). EPA's longstanding
interpretation is that corrective action may be required under RCRA
section 3008(h) at facilities which have or should have had interim
status, as well as some facilities that had interim status at one time
but no longer do (e.g., facilities that have lost interim status under
RCRA interim status section 3005(e)(2) and facilities which
[[Page 19454]]
have clean closed under interim status), or have failed to properly
obtain interim status. In addition, the 1990 proposal explained that
issuance of a permit does not automatically terminate the effectiveness
of a previously issued 3008(h) order.
Other enforcement authorities which can be used to issue corrective
action orders include RCRA sections 3013 and 7003. RCRA section 7003
provides EPA the authority to take enforcement actions to compel
corrective action where solid or hazardous waste may present an
imminent and substantial endangerment to human health or the
environment. RCRA section 3013 provides EPA the authority to require
investigations and studies where the presence or release of hazardous
waste may present a substantial hazard to human health or the
environment. All corrective action orders may be issued unilaterally by
the Agency or as consent agreements between the respondent and the
Agency.
F. Public Participation and Environmental Justice
EPA is committed to providing meaningful public participation in
all aspects of the RCRA program, including RCRA corrective action. In
1993, the Agency released a detailed guidance manual on public
participation (RCRA Public Involvement Manual, EPA 530-R-93-006). EPA
followed this guidance in December 1995 with the RCRA Expanded Public
Participation rule (60 FR 63417, December 11, 1995). EPA is also
committed to the principles of environmental justice and equitable
public participation. One of the Agency's central goals in the RCRA
program is to provide equal access to information and an equal
opportunity to participate. EPA continues to regard public
participation as an important activity that empowers all communities,
including minority and low-income communities, to become actively
involved in local waste management activities. EPA strives to provide
adequate public participation opportunities to all communities, putting
forth additional effort, where appropriate, to reach communities that
have not been involved in the past.
When corrective action is part of the RCRA permitting process, it
follows the procedural requirements set forth in 40 CFR Parts 124 and
270. Under these requirements, the corrective action provisions in any
permit application are available for public review throughout the
permitting process and the public can comment on them at the draft
permit stage.
The RCRA Expanded Public Participation rule creates more
opportunities for public participation in the RCRA permit
process.8 Additional opportunities of public participation
include: (1) A prospective applicant must advertise and hold an
informal public meeting before submitting an application for a RCRA
permit; (2) the permitting Agency must mail a notice to the facility
mailing list when the facility submits its permit application, telling
members of the public where they can examine the application during
Agency review; and (3) giving the permitting Agency the authority to
require a facility owner/operator to set up an information repository
at any time during the permitting process or the permit life. EPA
anticipates that these provisions, combined with existing public
participation requirements, will provide community members with
significant opportunities for early input and access to information.
---------------------------------------------------------------------------
\8\ The RCRA public participation rule is generally effective
only in states which have amended their authorized hazardous waste
programs to adopt the public participation rule requirements. At a
minimum, all authorized states are scheduled to make such amendments
by July 1, 1997. The exceptions are the following states and
territories where EPA implements the entire RCRA hazardous waste
program, including the public participation rule: Alaska, Hawaii,
Iowa, Puerto Rico, the Northern Mariana Islands, the Virgin Islands
and American Samoa.
---------------------------------------------------------------------------
In addition to the new requirements in the RCRA public
participation rule, EPA is using guidance to help facility owner/
operators meet the Agency's public participation goals. In the preamble
to the RCRA Expanded Public Participation rule, EPA encourages agencies
and facilities to use all reasonable means to ensure equal
opportunities for participation and equal access to information. These
means may include, but are not limited to, multilingual notices and
fact sheets, as well as translators, in areas where the affected
community contains significant numbers of people who do not speak
English as a first language. The Agency expects all those involved in
implementing corrective action to make good faith efforts to meet these
objectives in all permitting processes, including corrective action. In
the near future, EPA will issue further guidance to assist facilities
and permitting agencies in providing full and equitable public
participation in corrective action activities.
EPA's policy is for corrective actions imposed or overseen using a
non-permit mechanism to have the same level of public participation as
that associated with permits. Although EPA typically has less control
over public participation during voluntary corrective actions, it
strongly encourages the use of public participation and will take into
account the level of public participation conducted by the facility
owner/operator when evaluating the acceptability of voluntary actions.
In the absence of final regulations specifically addressing public
participation during corrective action, program implementors and
facility owner/operators should develop public participation strategies
on a site-specific basis, consistent with existing public participation
requirements and the program goal of full, fair, and equitable public
participation. At a minimum, information regarding corrective action
activities (e.g., RFI and CMS reports) should be available to the
public and the public should be given an opportunity to review and
comment on proposed corrective action remedies.
G. Financial Assurance
RCRA section 3004(u) requires that, when corrective action cannot
be completed prior to permitting, RCRA permits contain corrective
action schedules of compliance and financial assurance. Financial
assurance is also typically included in corrective action orders. On
October 24, 1986, EPA proposed detailed regulations to govern financial
assurance for corrective action (FACA). The October 1986 proposal would
require owners or operators seeking an RCRA permit to demonstrate
financial assurance for completion of remedies. Proposed acceptable
mechanisms included trust funds, surety bonds guaranteeing performance,
letters of credit, the financial test, and the corporate guarantee.
These are similar to the mechanisms used to assure closure and post-
closure costs. In a subsequent memorandum, EPA clarified that insurance
would also be an acceptable mechanism. In addition to permissible
mechanisms, the October 1986 proposal provided that financial assurance
demonstrations would ordinarily be required at the time of remedy
selection (e.g., rather than at the time an RFI is required). The
proposal also discussed cost-estimating procedures, including the
periodic adjustment of cost estimates, for determining the amounts of
required financial assurance.
In the absence of final rules, program implementors and facility
owner/operators have the flexibility to tailor financial responsibility
requirements to facility-specific circumstances. In some instances,
however, industry has expressed concern with EPA's implementation of
the financial
[[Page 19455]]
assurance requirements. Representatives of the regulated community have
also expressed concern that the costs of providing financial assurance
divert resources from actual cleanup activities, and that it may be
difficult for facility owners/operators to provide assurance for future
work while simultaneously performing current work.
In Section V of today's Notice, EPA requests comments on these
concerns and on corrective action financial assurance in general. In
the interim, EPA emphasizes that program implementors should apply
financial assurance requirements flexibly and that their main goal
should be to ensure that remedies proceed expeditiously.
IV. Corrective Action Program Priorities
In the absence of detailed regulations, EPA and authorized states
have implemented the corrective action program based on guidance and
policies developed over the past ten years. EPA stresses that
implementation of the corrective action requirements must continue even
as the Agency considers improvements to the corrective action program.
EPA's key goals and implementation strategies for the corrective action
program are outlined below.
1. Prioritize the corrective action universe:
a. Meet the goal of assessing and prioritizing all hazardous waste
treatment, storage or disposal facilities by end of FY96.
b. Focus resources on high priority areas at high priority
facilities.
2. Increase the amount of corrective action:
a. Continue to authorize states for corrective action.
b. Do not duplicate work already performed by another Federal or
state program.
c. Encourage alternate state authorities to conduct analogous work
at RCRA facilities.
d. Utilize the expertise of other Federal/state agencies where
appropriate (e.g., the U.S. Fish and Wildlife Service for ecological,
wetlands issues).
e. Increase the number of voluntary actions, including actions at
facilities without a permit or an order, actions outside of an existing
permit or order, and actions required under permit or order but with no
Agency oversight.
f. Disinvest or substantially reduce oversight at lower priority
facilities and high priority facilities where the owner/operator has
proven his or her capability.
3. Continue to implement the stabilization initiative:
a. Implement stabilization actions as early in the process as
possible.
b. Phase and focus RFIs to collect any information needed to
implement stabilization actions.
c. Use existing corrective action program environmental indicators
as stabilization performance measures.
d. Include meaningful opportunities for public participation
throughout the process including during extensive or long-term
stabilization actions.
4. Streamline the corrective action process where possible:
a. Implement stabilization actions where possible, then disinvest
and move on to other facilities.
b. Focus RFI data collection and tailor investigations to specific
site conditions.
c. Use existing pertinent data.
d. Communicate remediation expectations to facility owners/
operators early in the process.
e. Use innovative technical tools, including new site
characterization techniques and treatment technologies when appropriate
and beneficial.
f. Avoid unnecessary procedural steps whenever feasible (e.g.,
eliminate the CMS if a desirable remedy can be identified without one).
g. Use presumptive remedies when appropriate.
h. Focus on plausible remedies, if a CMS is necessary.
i. Conduct CMS concurrent with RFI when possible.
j. Utilize site-specific performance standards instead of detailed
review of work plans and remedy designs when possible.
k. Consider non-residential land use scenarios when appropriate,
while recognizing that ecological risks may end up driving media
cleanup standards and remedy designs when using industrial land use
assumptions.
5. Continue to involve the public in all stages of the corrective
action process.
V. Request for Comment and Data
EPA has the benefit of more than ten years experience in corrective
action implementation as it begins the Subpart S Initiative. The Agency
is committed to using this experience to identify, develop, and
implement improvements to the speed, efficiency, protectiveness and
responsiveness of the corrective action program as part of the Subpart
S Initiative. Today, EPA requests information, comments and data to
assist in this process. Some of the topics discussed in this section
raise new concepts that would likely warrant re-proposing regulations
or developing new guidance documents; others were addressed in the 1990
proposal but are included in this section of today's Notice because the
Agency is requesting additional comment and data at this time. EPA
requests that commenters be as specific as possible in their responses
to today's requests. The Agency is particularly interested in comments
which rely on actual experience in corrective action implementation and
include specific suggestions for improvement to the corrective action
program. The Agency also requests that commenters keep in mind the
objectives of the Subpart S Initiative: create a consistent, holistic
approach to cleanups at RCRA facilities; establish protective,
practical cleanup expectations; shift more of the responsibilities for
achieving cleanup goals to the regulated community; focus on
opportunities to streamline and reduce costs; and, enhance
opportunities for timely, meaningful public participation.
EPA emphasizes that its purpose in requesting comments at this time
is to take advantage of information and experience gained through
program implementation to aid in identification and development of new
proposals and to determine which portions of the 1990 proposal should
be promulgated immediately. EPA will consider all comments submitted in
response to today's Notice in development of the Subpart S Initiative.
Comments submitted during the 1990 comment period will be considered
before the Agency takes final action on any part of the 1990 proposal.
If EPA later proposes new corrective action regulations, full public
notice and opportunity for comment will be provided at that time.
A. General
EPA requests general comment on its implementation of the
corrective action program to date and on the strategy, goals and
schedule of the Subpart S Initiative as discussed in Sections II and IV
of today's Notice. The Agency is especially interested in comments
which include suggestions for specific improvements to the corrective
action program based on actual implementation experiences. The Agency
is also interested in examples of situations where the existing
flexibility in the corrective action program has been used to expedite
facility cleanups and in examples of the corrective action program
providing too much or too little flexibility. Since the Subpart S
initiative includes policy, guidance and rule development, commenters
should include specific recommendations for
[[Page 19456]]
additional policy or guidance development and address the balance
between guidance/policy documents and regulations (e.g., in 1990 EPA
proposed detailed regulations to address most aspects of the corrective
action program perhaps some of that information could be presented more
effectively in policy or guidance documents).
B. Resolution of the 1990 Proposal
EPA believes there may be elements of the 1990 proposal which have
been largely non-controversial or for which the issues have been fully
aired; accordingly, going through additional notice and comment on all
the issues raised by the 1990 proposal would not be necessary or, from
an efficiency standpoint, desirable. On the other hand, many issues
raised by the 1990 proposal have evolved during the past six years of
corrective action implementation, necessitating additional
opportunities for public notice and comment. In the discussions to
follow, EPA identifies the issues on which it believes further public
input is most needed. EPA also requests that commenters identify any
other issues, or elements of the 1990 proposal, on which they believe
it would be inappropriate for the Agency to take final action without
re-proposal. At the same time, EPA requests that commenters identify
specific elements of the 1990 proposal which could be promulgated
without additional public review and the advantages or disadvantages of
immediately promulgating such provisions. Comments submitted in
response to this request will be considered part of the administrative
record for the 1990 proposal; however, commenters should keep in mind
that EPA's intent is not to request new comment on the specifics of the
1990 proposal. Comments submitted during the 1990 comment period will
be considered before the Agency takes final action on any part of the
1990 proposal.
C. Focusing the Corrective Action Program on Results
As discussed earlier in today's Notice, the goal of the corrective
action program is to appropriately stabilize and clean up RCRA
facilities in a timely way. EPA believes that too often program
implementors and facility owners/operators may lose sight of this goal
and become distracted by processes. On the other hand, the purpose of a
standardized cleanup process is to ensure that the program is
implemented consistently and that all facilities appropriately meet
cleanup goals. The Agency is interested in improving the corrective
action program's focus on cleanup goals and requests general comment on
the balance between focusing on results and ensuring an appropriate
level cleanup at all facilities. In addition, EPA is specifically
interested in comments which address:
1. Performance Standards
EPA believes that focusing the corrective action program on
compliance with clear measurable performance standards rather than a
prescriptive corrective action process could significantly increase the
pace and quality of corrective action cleanups. Corrective action
performance standards could be part of a larger Agency effort to
develop results-based measures. The Government Performance and Results
Act of 1993 (GPRA) requires EPA to develop and implement results-based
measures across its programs by 1998. For example, the corrective
action environmental indicators (discussed below), were developed, in
part, in response to the GPRA. The Agency will consider any
performance-based approaches developed as part of the Subpart S
Initiative as it develops its implementation plan for the GPRA.
Reliance on performance standards, however, can raise a number of
implementation issues. For example, some stakeholders have suggested
that using performance standards in lieu of detailed review and
approval of work plans may increase the risk that individual facility
owners/operators will attempt to obscure or avoid legitimate corrective
action obligations. Stakeholders have also expressed concern about
potential reductions in public participation when corrective action
activities occur with reduced Agency oversight. In addition, some
elements of corrective action may be difficult to specify as
performance standards, and measuring, documenting compliance with, and
enforcing performance standards can be difficult for facility owners/
operators and overseeing agencies. EPA requests general comment of the
use of performance standards in the corrective action program. The
Agency is particularly interested in comments which address the details
of documenting and measuring compliance with performance standards and
in approaches to ensure adequate public involvement in performance-
based corrective action activities. In addition, as discussed in
Section II.E.2 of today's Notice, the corrective action program
currently has two environmental indicators covering human exposures
controlled and groundwater releases controlled. The Agency requests
comments on the development of additional environmental indicators; the
Agency is specifically interested in indicators targeted at ecological
risks.
2. Less Focus on Solid Waste Management Units
Use of the solid waste management unit (SWMU) concept as discussed
in the 1990 proposal has led to numerous unsuccessful permit appeals.
These permit appeals slow corrective action implementation and increase
the transaction costs. In certain cases, the SWMU concept may also
deter program implementors and facility owners/operators from
addressing contamination on a site-wide basis by focusing corrective
action resources unit-by-unit instead of more holistically.
In general, EPA believes that a holistic approach to corrective
action, as opposed to a unit-by-unit approach, could increase cleanup
efficiency and reduce transaction costs. EPA requests general comment
on focusing the corrective action program less on individual solid
waste management units and more on holistic approaches. The Agency
requests that commenters who support a less unit oriented corrective
action program also address whether there is any need for
clarifications to the corrective action jurisdiction language and/or
the SWMU definition in order to use such an approach.
D. Using Non-RCRA Authorities for Corrective Action
EPA recognizes that there are many authorities which could be used
to impose or oversee corrective action at any given facility.
Typically, these authorities include RCRA orders and permits, state
cleanup orders, and voluntary and independent actions. In some cases,
CERCLA authorities are also available. The Agency is concerned that, to
date, it has not taken full advantage of the work of other programs in
the RCRA corrective action program. In principle, EPA believes that
when a facility is being adequately addressed it should not matter what
authority is used or what Agency is overseeing the cleanups. In support
of this principle, the Agency requests general comment on the use of
non-RCRA authorities to satisfy corrective action requirements.
Commenters should address the scope and stringency of non-RCRA
authorities as compared to corrective action requirements and the
ability of non-RCRA authorities to adequately involve the public and
affected communities.
[[Page 19457]]
The Agency is also specifically interested in comments which address:
1. State Cleanup Programs
Over half the states have independent Superfund-like authorities
and cleanup programs; typically, these authorities and cleanup programs
are modeled after the Federal Superfund program. In many cases, EPA
believes these independent state authorities are substantively
equivalent in scope and effect to the RCRA corrective action program.
The use of state cleanup programs can offer a number of advantages
to state and regional personnel as well as to the regulated,
environmental and public interest communities. EPA believes these
advantages include: providing states the ability to recover the costs
of their program oversight; expanded opportunities for public
participation; the ability to recover damages associated with
contamination caused by previous owners or operators who would likely
not be considered liable under RCRA sections 3004(u) and 3004(v); and,
opportunities for voluntary or independent cleanups.
Many states are already using their independent Superfund-like
authorities to address releases of hazardous waste and hazardous
constituents at facilities subject to corrective action, especially at
facilities operating under interim status. The Agency is interested in
exploring the relationship between independent state Superfund-like
authorities and the corrective action program and, if appropriate,
providing some level of assurance that facility owners/operators who
complete cleanups under independent state authorities have satisfied
RCRA corrective action obligations.
EPA requests general comment on the use of state Superfund-like
cleanup programs to compel or conduct cleanups at facilities subject to
RCRA corrective action. EPA is especially interested in comments which
address:
(a) Scope. Whether the scope and effect of state Superfund-like
cleanup programs are substantively equivalent to the scope and effect
of the RCRA corrective action program.
(b) Advantages/Disadvantages. Advantages and disadvantages which
might be associated with using a state Superfund-like cleanup
authority, rather than, or in addition to, an RCRA corrective action
authority, at an operating hazardous waste management facility.
(c) Compliance with Federal Standards. The degree to which
compliance with state Superfund-like authorities should be assumed to
meet corrective action requirements, including procedural requirements
such as public participation and permitting.
(d) Coordination with RCRA Permits. Issues which might be
associated with coordination of state Superfund-like cleanup orders
with RCRA permits and Federal RCRA corrective action orders.
2. Enhanced Flexibility for States With EPA-Endorsed CSGWPPs
Current EPA policy is to provide states greater flexibility for the
management and protection of their groundwater resources. This policy
was stated formally in a report titled, ``Protecting the Nation's
Ground Water: EPA's Ground Water Strategy for the 1990s'' (Publication
21Z-1020, July 1991). The 1991 report indicated that, to the extent
authorized by EPA statute and consistent with Agency program
implementation objectives, EPA will defer to state policies,
priorities, and standards once a state has developed an adequate
groundwater protection program. EPA provided a definition of an
adequate state groundwater protection program in a December 1992
guidance titled, ``Final Comprehensive State Ground Water Protection
Program Guidance'' (EPA 100-R-93-001). The focal point of the 1992
guidance was the creation of Comprehensive State Ground Water
Protection Programs (CSGWPPs). As discussed in the 1992 guidance,
CSGWPPs are intended to provide a more efficient, coherent, and
comprehensive approach to protecting the nation's groundwater
resources.
Developing a CSGWPP is a three-stage process. First, a state
develops a ``core CSGWPP'' and submits it to EPA for review and
endorsement. The core CSGWPP is only required to include one
groundwater protection or remediation program to demonstrate whether
the state's CSGWPP approach inconsistent with EPA guidance. Second,
after the core CSGWPP is endorsed by EPA, joint state-EPA discussions
are held to develop a ``multi-year planning agreement.'' The multi-year
planning agreement will establish methods and a schedule for
incorporating other state groundwater programs into the CSGWPP. Third,
at the completion of the multi-year planning process, all groundwater
protection and remediation programs conducted in the state, including
Federal remediation programs, are included in a ``fully integrating
CSGWPP.''
At the time of today's Notice, EPA has endorsed five state core
CSGWPPs; endorsement of thirteen more is anticipated by June 1996. EPA
is committed to taking actions within its own programs to provide
states with endorsed CSGWPPs greater flexibility in protecting their
groundwater resources. The Agency has recently affirmed this commitment
in, ``EPA's Commitments to Support Comprehensive State Ground Water
Protection Programs'' EPA, 100/R-94/002, date. In the RCRA corrective
action program, EPA committed to considering state groundwater
classification when making groundwater use assumptions, selecting
groundwater cleanup levels, and setting cleanup priorities.
EPA is interested in evaluating additional opportunities to provide
states with endorsed CSGWPPs enhanced flexibility in implementation of
the RCRA corrective action program. EPA requests comments and
suggestions on specific areas of flexibility that should be available
in states with endorsed CSGWPPs. The Agency is also interested in
suggestions and comments addressing areas where a distinction in the
amount of flexibility afforded to states with an EPA-endorsed CSGWPPs
would not be appropriate. For example, should states with EPA-endorsed
CSGWPPs be provided greater flexibility than states without endorsed
CSGWPPs in specifying groundwater cleanup levels, points of compliance
or compliance time-frames based on state determination of current and
future groundwater uses as recorded in an EPA-endorsed CSGWPP?
Similarly, should states with EPA-endorsed CSGWPPs be given additional
flexibility to prioritize oversight resources or facility-specific
corrective action schedules?
3. Voluntary Corrective Action
EPA requests comments on the use of state voluntary cleanup
programs to accelerate cleanups at facilities subject to RCRA
corrective action and the roles of EPA and states in such situations.
EPA is specifically interested in comments which address:
(a) Use of state voluntary cleanup programs at RCRA corrective
action facilities. Over half the states have developed voluntary
cleanup programs; these state voluntary cleanup programs vary
significantly in program design, the degree to which the state offers
guidance and oversight during the cleanup process and the review, if
any, of the final cleanup. EPA is interested in comments which address
the use of state voluntary cleanup programs to accelerate corrective
action at RCRA facilities including the level of Federal review or
endorsement, if any, necessary for such programs. Commenters who
support Federal review or endorsement should address program criteria
(e.g., protectiveness,
[[Page 19458]]
public participation) that EPA should use to evaluate state voluntary
cleanup programs used to satisfy corrective action obligations.
(b) Incentives for private parties to accelerate corrective
actions. EPA recognizes that many facility owners/operators who might
be inclined to accelerate corrective action voluntarily at their
facilities may choose not to because of concerns that the Agency might
``second-guess'' the cleanup conducted and impose additional
requirements. EPA requests comments on incentives which can be offered
to encourage facility owners/operators to voluntarily accelerate
corrective action at their facilities including approaches which could
be used to provide comfort or assurance to facility owners/operators
who complete corrective action under a state voluntary program. In
addition, the Agency requests comments on the degree to which
accelerated corrective action should be based on compliance with
general performance standards or, alternatively, more detailed guidance
documents or regulations. Commenters who support the use of guidance
should specify whether guidance should be developed at the state or
Federal level, and list the existing documents that they believe would
be applicable.
(c) Specific site eligibility for accelerated corrective action. In
some state voluntary cleanup programs, site eligibility for voluntary
cleanup is limited to sites which are considered low risk (e.g., sites
where the contamination is not highly concentrated or highly toxic).
EPA requests comments on site eligibility for accelerated corrective
action and whether eligibility should in any way be limited based on
the degree of health or environmental threat present at any given
facility. The Agency is specifically interested in comments which
address whether, or to what extent, facilities already under real-time
Agency oversight should be allowed to switch to an accelerated action
pursuant to a state voluntary cleanup program.
(d) Public participation. EPA believes that meaningful
opportunities for public participation are essential to a successful
corrective action program; it requests comments on the specific
opportunities and procedures for public participation which should be
included in any voluntary corrective action program.
(e) Review of accelerated actions. EPA anticipates that some level
of review by the implementing state agency will be necessary to ensure
that accelerated corrective actions are of sufficient quality to
fulfill corrective action requirements. The Agency requests comments on
the level of review by the implementing state agency, if any, necessary
to ensure the quality of accelerated corrective actions. Commenters who
believe some level of review is necessary should address the timing and
substance of the review (e.g., audits of facility actions and records,
review of milestone documents), and the role, if any, of EPA in the
review process.
(f) Third-party oversight. Several states have established cleanup
programs which rely on a licensed third-party overseer, rather than
implementing agency staff, to ensure compliance with cleanup
requirements at certain facilities. One state requires an independent
third-party overseer to monitor compliance with all phases of the
cleanup process at facilities and certify to the implementing agency
when cleanup at a facility is complete. EPA believes such approaches
may reduce the risks associated with voluntarily accelerated cleanups
and provide necessary relief to state regulators. While development of
a third-party oversight system is not currently under consideration at
the Federal level, EPA requests comments on the use of state third-
party oversight programs for oversight of cleanups at facilities
subject to RCRA corrective action.
4. Corrective Action at Interim Status Facilities
In 1990, EPA proposed that corrective action regulations be
included in 40 CFR Part 264 (the permitting standards). The only
changes proposed to 40 CFR Part 265 (the interim status standards) were
to address the need to coordinate corrective action and closure
activities at closing interim status units and facilities. EPA's
longstanding view has been that the requirements to address facility-
wide corrective action at interim status facilities are consistent with
those for permitted facilities. For this reason, the Agency requests
comments on whether the corrective action regulations should be
developed under 40 CFR Part 265 as well as under Part 264. The Agency
is especially interested in comments which address the trigger for
initiation of corrective action activities at interim status
facilities, the degree to which any corrective action requirements
included in 40 CFR Part 265 would be independent or self-implementing
(see, discussion of independent or self-implementing corrective action,
below), and the incorporation of corrective action activities conducted
while facilities are under interim status into final facility permits.
In addition, EPA requests comments on further modifying the interim
status requirements to include provisions for the cleanup of releases
to groundwater from regulated units equivalent to those at 40 CFR
264.100.
5. Independent or Self-Implementing Corrective Action
EPA believes that the 1990 corrective action proposal appropriately
emphasized the need for flexibility and site-specific decisions;
however, the administrative framework proposed in 1990 relies on
intensive oversight by a regulatory agency. In general, corrective
action facility owners/operators initiate a cleanup only after being
compelled to do so by a regulatory agency (e.g., in an order or
permit). The regulatory agency then reviews and approves intermediate
steps, such as work plans and reports, ultimately selects the remedy,
and ensures that the remedy is implemented and achieves cleanup
objectives. This command and control approach reduces risks associated
with all phases of cleanup at a facility; however, it is resource
intensive and may discourage facility owners/operators from undertaking
voluntary or accelerated cleanup actions.
Due to limited oversight resources, many of the lower risk
facilities which are believed to require some form of corrective action
have remained unaddressed. This issue has raised concerns about the
pace and quantity of corrective action cleanups. In order to address
these concerns and shift more of the responsibility for conducting
corrective action activities to the regulated community, EPA is
examining approaches to independent or self-implementing corrective
action. By ``independent'' or ``self-implementing'' the Agency is
referring to activities required by regulation to meet certain
standards of performance within specified time periods without direct,
real-time, oversight by a regulatory agency. For example, the RCRA
regulations for hazardous waste characterization require generators of
solid waste to determine if such wastes are considered hazardous wastes
and, if hazardous, to manage them appropriately. Generators notify
overseeing agencies of their waste determinations and management
(through the biannual reporting and manifesting systems) and overseeing
agencies periodically audit or inspect generator compliance. Similarly,
EPA believes some corrective action activities could be sufficiently
prescribed by regulation and carried out independently by facility
owners/operators subject to auditing by an overseeing agency, rather
than being
[[Page 19459]]
specified in facility specific order or permit conditions. For example,
facility owners/operators could be required, upon identification of a
release of hazardous waste or hazardous constituents at or from the
facility, to conduct an initial screening investigation and take
appropriate steps to control the release. In another example, facility
owners/operators could be required to take whatever steps are necessary
to certify compliance with EPA's two environmental indicators for
corrective action. (As discussed in Section II.E.2 of today's Notice,
the two environmental indicators for corrective action are human
exposures controlled and groundwater releases controlled.)
EPA believes that applying the concept of self-implementation to a
cleanup scenario raises many issues. For example, the complexity and
site-specific nature of corrective action, coupled with the fact that
it requires the exercise of professional judgement (e.g.,
hydrogeologic, engineering) throughout the process, may make self-
implementation problematic. These same factors may make compliance
monitoring and enforcement difficult. The Agency's experience with the
self-implementing groundwater monitoring requirements in the interim
status standards (i.e., Part 265, Subpart F) is indicative of the
difficulties that may be associated with ensuring full compliance with
self-implementing standards. The Agency is interested in general
comment on the concept of independent or self-implementing corrective
action; it is specifically interested in comments which address:
(a) Scope. EPA requests that commenters specifically identify the
elements of the corrective action process which they believe are
amenable to self-implementation.
(b) Public participation. Meaningful public participation is
essential to the corrective action process. EPA requests that
commenters address incorporation of public participation opportunities
and activities in self-implemented corrective action.
(c) Detailed guidance. An argument can be made that, without
detailed guidance for self-implemented activities, quality will vary
across actions. EPA requests that commenters address the degree to
which self-implementation should rely on detailed guidance and whether
the Agency should issue new guidance for self-implemented corrective
action or if EPA can rely on guidance already available at the state
and Federal level. Commenters suggesting that EPA rely on existing
guidance should indicate the guidance documents they believe would be
applicable. The Agency is also interested in comments which address
approaches to ensure that facility owners/operators have access to and
use current and appropriate guidance documents.
(d) Record keeping and reporting. Facility owners/operators might
be required to submit information certifying and documenting their
compliance with self-implementing requirements. Information and
documentation which EPA could use to assess the quality of self-
implemented actions might also be necessary. EPA requests that
commenters address whether or not Record keeping and reporting
requirements should be part of self-implementing corrective action.
Commenters who support Record keeping and reporting requirements should
address the specific requirements they believe are necessary.
(e) Compliance Monitoring and Enforcement. Compliance with self-
implementing requirements might be monitored through regular
inspections or periodic auditing. EPA requests comments on the ability
of state or Federal overseeing agencies to adequately monitor and
enforce self-implementing requirements. EPA requests that commenters
specifically address its ability to accurately assess the quality of
self-implemented corrective actions without ongoing Agency oversight.
(f) Risks. Any reduction in real-time agency oversight increases
the risks that individual facility owners/operators might attempt to
avoid or obscure legitimate corrective action obligations. EPA requests
comments on the potential risks associated with self-implementation of
certain corrective action provisions and suggestions of actions that
the Agency could take to eliminate or mitigate such risks.
6. Consistency with the CERCLA Program
As discussed in Section III.B.1 of today's Notice many facilities
subject to corrective action are also subject to cleanup under the
Federal CERCLA program. At some of these facilities, RCRA corrective
actions are proceeding concurrently with CERCLA cleanups (e.g., the
RCRA corrective action is addressing SWMUs while the CERCLA cleanup is
focusing on other releases). At other facilities, cleanup is being
addressed by one authority but final action under the other authority
is being deferred (e.g., a site undergoing RCRA corrective action but
still on the NPL). In general, EPA believes coordination of cleanup
activities at facilities with overlapping RCRA and CERCLA liability is
appropriate; however, the Agency continues to hear concerns over
duplication of procedural and substantive cleanup requirements,
including oversight. Recently, EPA established a multi-agency and state
workgroup to examine issues associated with overlapping cleanup
obligations. Through the ``Lead Regulator Workgroup'' the Agency hopes
to identify specific strategies for expediting cleanups though reducing
or eliminating the transaction costs that may be associated with
overlapping cleanup obligations. The Agency requests comments on the
issue of coordination of overlapping RCRA and CERCLA cleanup
requirements and suggestions for improvement to the Agency's current
policy and regulatory approaches to coordination. For example, would
using of the same terms for remedial activities, such as investigations
or remedy selection, improve coordination at sites with overlapping
RCRA corrective action and CERCLA cleanup obligations? Similarly,
should the remedy selection criteria between the two programs be
explicitly conformed?
While EPA's focus is on coordination between the RCRA and CERCLA
programs, it also requests comments on coordination of overlapping
state and Federal cleanup obligations.
7. ASTM RBCA Standard
EPA expects the number of identified releases from underground
storage tanks (USTs) to increase to more than 400,000 as the 1998
deadline for upgrading, replacing, or closing UST systems approaches.
To meet the challenge of addressing these releases in a timely manner,
EPA is working with states to streamline their administrative processes
and to encourage the use of expedited site assessment and alternative
cleanup technologies. The Agency is also encouraging state and local
agencies to incorporate risk-based decision-making into their
corrective action programs.
Risk based decision-making is a process UST implementing agencies
can use to: focus site assessment data gathering; conduct initial
response actions; categorize or classify sites; determine what, if any,
further action is necessary to remediate a site; help establish cleanup
goals; and decide on the level of oversight provided to cleanups
conducted by UST owners and operators. To provide support for the use
of risk-based decision-making, EPA's Office of Underground Storage
Tanks, within the Office of Solid Waste and Emergency Response (OSWER),
issued Directive 9610.17: Use of Risk-
[[Page 19460]]
Based Decision-Making in UST Corrective Action Programs. The American
Society for Testing and Materials (ASTM) has also developed guidance
addressing risk-based decision-making in its recently issued standard
ASTM E1739-95, Risk Based Corrective Action Applied at Petroleum
Release Sites (referred to as RBCA). The ASTM standard is one example
of how risk-based decision-making can be incorporated into state UST
corrective action programs. EPA believes the ASTM standard may be a
good starting point for the development of a risk-based process
tailored to applicable state and local laws and regulatory practices.
In addition, state UST RBCA processes may often be applicable to
petroleum releases from sources other than leaking USTs.
EPA requests general comment on the use of the ASTM RBCA approach
in the corrective action program; it is especially interested in
comments which address: the appropriateness of using RBCA-like programs
to address releases from sources other than leaking underground storage
tanks (e.g., petroleum spills and contamination at refineries); whether
the ASTM RBCA approach is acceptable for releases of chemicals other
than petroleum products; and, whether there have been, or could be,
conflicts between the result of a cleanup conducted using the ASTM RBCA
approach and cleanups conducted using the RCRA corrective action or
CERCLA approaches.
8. Definition of Facility for Corrective Action
As discussed in Section III.B.3.a of today's Notice, EPA's
definition of facility for purposes of corrective action has been
problematic in some situations. In certain circumstances, the concept
of contiguity can bring large tracts of land not involved with
hazardous waste management under corrective action authorities. In many
cases, these large tracts of land are being (or could be) addressed
using another cleanup authority (e.g., CERCLA or state cleanup
programs); in other cases, they may not be a high priority for cleanup.
For example, EPA indicated in the 1990 proposal that, if five acres of
a one hundred-acre parcel of land were leased to a company that engaged
in hazardous waste management, the facility for purposes of corrective
action could be the entire 100-acre parcel. EPA also stated that if (in
the same example) the lessee/operator also owned 20 acres of land
adjacent to the 100-acre parcel (but not necessarily adjacent to the
five acres used for hazardous waste management), the facility might
include that 20 acres as well. (See, 55 FR 30808, July 27, 1990.) In
practice, EPA has found that imposing this interpretation of contiguity
on situations such industrial parks, port districts, and large areas of
Federally owned land (e.g., national forests) can, in some cases, force
the Agency to address sites which are not engaged in hazardous waste
management and which may not be a high priority for cleanup using
limited corrective action resources. Another concern has been that it
may be seen as inequitable to require the operator of a small facility
to be responsible for the cleanup of a much larger parcel that he or
she does not own. Accordingly, EPA is requesting comment on whether
corrective action requirements should apply more narrowly (e.g., only
to the portion of the facility under the control of the operator
engaged in hazardous waste management). EPA requests that commenters
endorsing a narrow definition of facility address the concern that it
would encourage facility owners/operators to narrowly define their
facilities in an effort to avoid legitimate corrective action
obligations and also address other potential consequences and concerns,
if any, of a facility definition which is too narrow.
E. Balance Between Site-specific Flexibility and National Consistency
To account for the variety of circumstances at corrective action
facilities, EPA has emphasized a flexible, facility-specific approach
to cleanup; however, using a facility-specific approach can raise
issues associated with national consistency and minimum national
standards. The Agency requests general comment on the appropriate
balance between national consistency and site-specific decision-making
in the corrective action program. The Agency is specifically interested
in comments which address:
1. Land Use
EPA has been criticized for too often assuming that the future uses
of facilities undergoing cleanups will be residential. Residential use
is considered unrestricted land use and carries the greatest potential
for exposures and the most conservative exposure assessments. As
discussed in Section III.C.5.j of today's Notice, the Agency believes
that the 1990 proposal adequately provides for reasonable consideration
of future land use during development of remedial goals at corrective
action facilities; however, it recognizes that the uncertainties
surrounding land use assumptions may cause many program implementors
and facility owners/operators to choose a conservative approach to
future land use issues. Today the Agency invites comment on the general
issues associated with consideration of future land use in the
corrective action context. EPA is specifically interested in comments
which address:
(a) Effect. EPA is interested in comments on the effect of a non-
residential land use determination on a facility owner/operator's
corrective action obligations and the need (if any) for additional
regulations to address incorporation of land use determination in the
corrective action process. For example, how, if at all, should non-
residential land use determinations affect the scope of facility
investigations? Should land use determinations be explicitly required
as part of remedy selection?
(b) Institutional controls. When final remedies rely on non-
residential exposure assumptions, steps must be taken to ensure the
non-residential exposure assumptions remain valid and to trigger
additional cleanups should exposures change. EPA is interested in
comments which address the role of the government, if any, in ensuring
the continued application of exposure assumptions and in imposing
additional cleanups as necessary. In addition to the role of
government, commenters should list other factors, incentives or
institutions they believe will play a role in this process. The Agency
is particularly interested in comment on the adequacy of institutional
controls (e.g., deed notices, easements, or local land use controls) to
ensure that changes in land use trigger additional cleanups as
appropriate, the advantages or disadvantages associated with such
controls as opposed to direct governmental oversight.
(c) Additional cleanup necessitated by changing land use. EPA
requests that commenters specifically address completion of any
additional increment of cleanup necessitated by changing land use. The
Agency is also interested in comments which address the continuing
obligation, if any, of the facility owner/operator to ensure that
(should land use change) additional cleanups will be effected, the
obligation (if any) on the person who changes the land use at the
facility, the legal mechanisms that might be used to impose these
obligations, the role of the Agency and/or facility owner/operator in
monitoring land use changes and the necessity, if any, for the facility
owner/operator or others to provide financial assurance in case an
additional cleanup should become necessary.
(d) Periodic review of remedies. The Superfund program periodically
reviews
[[Page 19461]]
remedies to ensure their continued effectiveness. EPA requests
commenters address the need for and potential benefits or problems
associated with periodic review of RCRA corrective action remedies.
Commenters who believe periodic review of remedies is desirable should
address the frequency and content of such reviews.
2. Points of Compliance
The location at which media cleanup levels must be attained (point
of compliance or POC) has significant implications for the scope,
magnitude and cost of corrective actions. Comments regarding the POC
for corrective actions were received in response to the 1990 proposal;
this issue has remained controversial and EPA believes it is
appropriate to provide another opportunity for public review and
comment at this time. The Agency requests general comment on its
implementation of the point of compliance concept in the corrective
action program and other POC issues. EPA is especially interested in
comments which address:
(a) Alternatives to the throughout-the-plume/unit boundary POC. EPA
requests suggestions on alternative POCs, especially groundwater POCs.
Commenters should address the factors, scenarios, and decision-making
criteria that should be considered in justifying alternatives to a
throughout-the-plume/unit boundary POC (e.g., a facility boundary POC).
In supplying input on alternative POCs for groundwater, commenters
should consider the Agency's expectations for groundwater cleanups, (1)
returning groundwater to its maximum beneficial uses wherever
practicable; (2) preventing or minimizing further migration, preventing
exposure to the contaminated groundwater and evaluating further risk-
reduction; and, (3) controlling or eliminating surface and subsurface
sources of groundwater contamination. Commenters who believe that
changes to EPA's expectations for groundwater are necessary to support
appropriate POCs are also invited to comment on EPA's groundwater
expectations in general.
(b) Points of compliance for stabilization. EPA requests comments
on whether it should develop a stabilization point of compliance or to
support the Stabilization Initiative. As discussed in Section II.E.1 of
today's Notice, the Stabilization Initiative is EPA's primary
corrective action implementation strategy. Stabilization actions for
groundwater often involve source control and hydraulic containment. A
stabilization point of compliance could be used to help define the
location at which a performance measure of groundwater plume
containment would be measured.
(c) Point of compliance for surface water. Typically, the point of
compliance for releases to surface water is at the point where the
release enters the surface water. EPA requests comments regarding
factors that should be considered in selecting the appropriate
standards that must be achieved at the point where the release enters
surface water. For example, is it appropriate to consider the mixing
that occurs within the receiving surface water when establishing points
of compliance for surface water discharges? Mixing zones are often
considered when evaluating the acceptability of waste water discharges
regulated by the National Pollution Discharge Elimination System
(NPDES).
EPA also requests comments on the differences between evaluating
the actual and potential impact from point source ``pipeline'' NPDES
discharge and a more widespread discharge of groundwater entering as
base-flow into the surface water body. Of particular interest
associated with groundwater discharge to surface water is the potential
for, and impacts from accumulation of contaminants in sediments. Also,
the Agency is interested in feedback regarding the degree to which
monitoring would be capable of assessing impacts of both the short- and
long-term discharge of groundwater to surface and the associated
standard of protection being afforded. The Agency is interested in
examples where a discharge to surface water of certain loadings of
contaminated groundwater was determined to be harmful or not harmful to
human or ecologic receptors.
3. Standardized Lists of Action Levels and Media Cleanup Levels
The attempt to balance flexibility with the need for national
consistency can be particularly contentious in the area of media-
specific action and cleanup levels. Some stakeholders argue that lists
of clearly defined action and cleanup levels will reduce transaction
costs, increase the pace of cleanups and encourage voluntary actions;
many program implementors and facility owners/operators currently use
lists of standardized action or cleanup levels when implementing
corrective action requirements (e.g., some states have lists of
standardized media-specific cleanup levels). Other stakeholders argue
that standardized lists of action or cleanup levels are too often
developed based on conservative residential exposure scenarios, can be
too easily misapplied, and often result in overly stringent cleanup
actions. As an alternative to lists of standardized action and cleanup
levels, some Agencies have developed standardized approaches (i.e.,
formulas) that allow for consideration of site-specific conditions. EPA
has recently taken this approach in developing the Superfund Soil
Screening Guidance (see, Section II.F.6.b of today's Notice).
EPA invites general comments and suggestions pertaining to the
development, distribution and use of media-specific action and cleanup
levels. The Agency is specifically interested in comments which address
the advantages, disadvantages and preferences regarding standardized
approaches verses publishing lists of standardized levels (note, lists
of standardized levels would be developed using standardized
approaches, the difference is in consideration of site-specific
factors, such as depth to groundwater). Since many states have already
developed standardized approaches or lists of action and cleanup
levels, EPA requests commenters also address the role of EPA in
developing, distributing, and periodically updating national approaches
or lists and the relationship of any standardized approaches or lists
developed at the national level to existing state programs.
4. Area Wide Contamination Issues
In some cases corrective action facilities are located in areas of
widely dispersed contamination. For example, some corrective action
facilities may be located in tidal areas which were reclaimed by
placement of fill materials now considered contaminated. In other
cases, an RCRA corrective action facility may be impacted by releases
from off-site source areas not subject to RCRA corrective action (e.g.,
sources at an adjacent facility not seeking an RCRA permit). In some of
these circumstances, cleanup of the corrective action facility to risk
based media cleanup levels, while desirable in the long term, might not
make sense in the short term because contamination from off-site or
otherwise unrelated sources would quickly re-contaminate the facility.
EPA requests comments on application of corrective action requirements
in areas of widely dispersed contamination and when the RCRA facility
is otherwise impacted by releases from off-site sources. EPA requests
that commenters specifically address the obligation, if any, a facility
owner/operator should have to address the area-wide contamination to
the extent it is present at his or
FR Doc. 96-9707 Corrective Action for Releases From Solid Waste Management Units at Hazardous Waste Management Facilities
her facility. If commenters
[[Page 19462]]
believe facility owners/operators should not be required to address
area-wide contamination, the Agency requests comments on the continuing
obligation under RCRA, if any, such facility owners/operators should
have for an eventual cleanup to risk based levels.
5. Ecological Risk
As described in Section III.C.5.g of today's Notice, EPA's mandate
is to protect both human health and the environment; therefore,
assessing risks to ecologic receptors may be warranted in the context
of implementing RCRA corrective action at many sites. The Agency
recognizes, however, that assessing impact to ecologic receptors from
environmental contamination is a rapidly evolving field of study.
Therefore, the Agency is interested in receiving comments and data
pertaining to: state-of-the-art approaches and tools for conducting
ecologic-risk assessment, including initial screening as well as
detailed assessments; availability of identification of useful
guidance; availability of standardized eco-based action levels and
cleanup levels, or standardized approaches for developing site-specific
levels; site-specific examples of impacts to ecologic receptors from
RCRA corrective action sites, and examples of successful remedial
actions implemented to address these impacts; limitations associated
with assessing ecologic risks, and taking remedial actions to protect
ecologic receptors in general; specific needs for additional guidance
and research; and suggestions regarding the scope of specific
corrective action regulations dealing with assessment and protection of
ecologic receptors.
6. Risk Assessment Methods
EPA has been criticized for relying on uniform, ``one size fits
all'' risk assessment methods, particularly in the context of its
remedial action programs. According to critics, often, the default
assumptions or models incorporated into Agency risk assessment guidance
documents do not adequately reflect site-specific conditions. The use
of empirical data collected from a site, or methods developed expressly
for application at specific sites or types of sites, could result in
more valid and reliable characterizations of risks to human health and
the environment. On the other hand, not every site would benefit from a
comprehensive site-specific evaluation. EPA thus needs to strike a
balance between the ease of uniform risk assessment methods and the
improved targeting and effectiveness associated with accounting for
site-specific conditions.
EPA is interested in the effect of provisions which would encourage
the expanded consideration of site-specific conditions and other
innovative risk assessment methods where such provisions would enhance
program effectiveness or efficiency. For example, how could the Agency
provide for the use of site-specific or innovative approaches to risk
assessment while still enabling EPA or state agencies to maintain
adequate oversight? Are there mechanisms available for risk assessment
to be independently validated as reasonable characterizations of site
risk, thereby reducing the demands for technical oversight and the time
required to approve site-specific decisions. What incentives (if any)
should EPA provide to encourage these efforts? What provisions or
procedures, either in the 1990 proposal or in existing regulations,
inhibit the effective use of site-specific risk assessments?
Significant improvements in risk assessment methodology have
occurred since the 1990 proposal. EPA is interested in capturing these
benefits in the corrective action program. The Agency thus seeks
comments concerning how RCRA corrective action regulations might be
constructed so as to maximize the extent to which these improvements
are reflected in site evaluations, as well as the development and
selection of remedial alternatives. Further, EPA is interested in
comments addressing actions the Agency could take to act as a positive
force for change in the evolutionary improvement of risk assessment
methods.
F. Public Participation and Environmental Justice
EPA intends for the final corrective action regulations to be
consistent with the Agency's efforts to improve permitting and public
participation while providing sufficient flexibility to meet site-
specific goals. The Agency believes that facility owners/operators,
state environmental agencies, tribes, and private citizens are often in
the best positions to determine what modes of communication and
participation will work best in their communities. EPA believes the
final rule should provide the flexibility necessary to find the best
local solutions.
EPA requests general comment on the role of public participation in
the corrective action program and on opportunities to improve public
participation, especially the participation of any communities which
have not been effectively involved in the corrective action process to
date. The Agency is particularly interested in comments which address:
(a) Public participation tools. Currently, most public
participation opportunities center around use of public notices
(usually in a local newspaper) and public meetings. EPA requests that
commenters address the use of additional public participation tools
(such as public participation plans, community advisory panels, fact
sheets, workshops, on-line communications, and informal meetings) which
might be more effective in reaching communities.
(b) Public participation responsibility. EPA believes there may be
situations where the corrective action process would benefit if the
facility initiated the permit modifications under 40 CFR 270.42, rather
than the Agency initiating permit modifications under 40 CFR 270.41.
For instance, if a facility owner/operator must undertake an interim
action, it may be more appropriate for the facility to request a permit
modification. EPA anticipates that allowing this flexibility would
improve interaction between the public and the facility and allow
owners/operators to streamline the process by combining modifications,
where appropriate. We request comment on this approach and the use of
owner/operator initiated permit modifications to provide public
participation opportunities.
(c) Tailoring public participation to the level of interest. EPA
encourages facility owners/operators and regulatory agencies to choose
a level of public participation that is commensurate with the level of
public interest. The Agency is aware of innovative approaches to public
participation where the level of public participation opportunities
increase dramatically if a certain number of citizens from the affected
community request increase public participation. The Agency realizes
that every corrective action process is different and may involve
overlapping and varied activities. EPA requests comments on public
participation tools which could be used to tailor public participation
opportunities to the level of interest in the affected community and to
the significance of any given corrective action activity. The Agency
requests that commenters who support tailoring public participation
requirements to the level of interest at any given facility also
address the degree to which the Agency or the facility owner/operator
should take steps to inform the public of the onset of corrective
actions to initiate public interest.
[[Page 19463]]
G. When Permits Can Be Terminated
The 1990 proposal contained a provision requiring owners and
operators to obtain RCRA permits for the entire ``period necessary to
comply with the requirements of Subpart S'' (proposed 40 CFR 270.1(c)).
As discussed in the preamble to the 1990 proposal (see, 55 FR at 30846)
this was intended to apply even where the hazardous waste management
activities that originally triggered the need to obtain a permit were
no longer continuing. The aim of this provision was to ensure that
corrective action was carried to its conclusion. Furthermore, EPA
believed that if corrective action obligations ceased when the need for
the permit otherwise ended, an artificial incentive would be created to
terminate viable facilities (e.g., facility owners/operators would
choose to curtail management of hazardous waste--and the need for an
RCRA permit--in to avoid completing corrective actions).
When the CAMU rule was promulgated, EPA reiterated its view that
facilities undergoing corrective action must continue to renew their
permits, even if the original regulated hazardous waste activity has
ceased, until the corrective action has been completed. See 58 FR at
8676-77. EPA clarified that this obligation arises under existing
statutes and regulations, even pending final promulgation of the
additional language proposed in 1990. EPA indicated at that time that
it would determine whether further regulatory clarification of this
issue was necessary.
At this time, EPA is inviting comment on whether, as a policy
matter, extended permitting is the best approach to ensuring that
corrective action is carried out over the long term, or whether other
alternatives should be considered. For example, one approach might be
to terminate the permit when active hazard waste management ceased, but
to continue the cleanup obligation through some other vehicle, possibly
an enforcement order. Any alternatives proposed should address such
matters as the reliability of the approach over the very long term, the
level of administrative oversight required, the legal basis in RCRA for
imposing the requirement if a permit is not issued and whether the RCRA
statute would allow terminating a permit before the corrective action
was complete. Commenters proposing alternatives are particularly
encouraged to address options for the situation where engineering or
institutional controls must be managed indefinitely into the future and
whether permits can or should be terminated when the final remedy
involves some form of engineering or institutional controls. Commenters
who support permit termination when final remedies involve engineering
or institutional controls are encouraged to address what other
mechanisms, if any, should be used to ensure continued reliability of
the engineering or institutional control and the role of EPA, if any,
in imposing, maintaining and enforcing such mechanisms.
H. Effect of Property Transfer on Corrective Action Requirements
The transfer of part of a facility subject to corrective action
creates questions regarding which corrective action obligations
continue at the transferred parcel and which party has the corrective
action responsibility. The 1990 proposal discussed this issue, and EPA
is still interested in general comments in this area. The 1990 proposal
identified two options: requiring the permittee to complete corrective
action even on parcels sold to others, and requiring the purchaser of
the parcel to complete the corrective action. EPA continues to be
interested in comments on these two options.
A related issue is the point in time at which the extent of the
facility is defined. For example, if a parcel were transferred after a
permit application had been submitted, but before a permit or
corrective action order was issued, the implications might be different
from if the transfer occurred after the permit was issued. The 1990
proposal also suggested that it might make a difference whether the
transfer occurred before implementation of the remedy. Since RCRA
corrective action requirements apply to the current owner and operator
of an RCRA facility and do not routinely extend to past facility
owners/operators, EPA believes there may be some incentive for facility
owners/operators to sell portions of their facilities before corrective
action requirements can be imposed. EPA is aware of situations where a
facility owner/operator has sold entire facilities, excluding only the
closed RCRA regulated units, in what seems to be an effort to avoid
application of RCRA corrective action requirements. While EPA has
numerous authorities that could be used to address cleanup requirements
even after portions of the facility had been sold, EPA believes
application of these other authorities, rather than RCRA corrective
action authorities, could increase transaction costs and delay
cleanups.
I. Financial Assurance for Corrective Action
Currently, Financial Assurance for Corrective Action or FACA is
required under 40 CFR 264.101. More detailed requirements for financial
assurance for corrective action were proposed on October 24, 1986 (51
FR 37854) and in the 1990 proposal. EPA requests general comment on the
need for detailed corrective action financial assurance regulations and
the utility of the 1986 and 1990 proposals as guidance in this area.
Commenters should address whether regulations or guidance would better
promote the goals of the corrective action program and financial
assurance for corrective action, and whether the flexibility inherent
in the FACA proposals has been useful or detrimental. In addition, EPA
is interested in comments which address:
(a) Timing of financial assurance. EPA requests commenters address
both the stages in the corrective action process where FACA
requirements have proven most useful (e.g., should financial assurance
be required before a remedy is selected, perhaps to ensure completion
of facility investigations) and the stages, if any, where FACA
requirements have been of limited utility. In its previous notices, EPA
has said that financial assurance should be required at the time of
remedy selection. Is this still an appropriate policy? EPA is
especially interested in comments that address whether financial
assurance has been an impediment to corrective actions due to the
investment entailed. In addition, the Agency requests comments on how
the amount of financial assurance required should be determined. For
example, should financial assurance be required for operation and
maintenance costs in perpetuity or should it be required for a
standardized length of time (e.g., five, ten or twenty years)? Should
the financial assurance timing be adjusted to address interim measures
and support the stabilization initiative? Because cost estimations at
certain stages in the process can be inaccurate, should financial
assurance requirements cover shorter time frames, such as two years?
Should EPA be concerned with financial assurance for short term
investigation and construction costs, or should we focus on assuring
long term operations and maintenance expenses?
(b) Design of a FACA rule. Commenters who believe that EPA should
promulgate detailed regulations on financial assurance for corrective
action should address the design of such rules. Alternatively, are the
current general rules sufficient or more
[[Page 19464]]
appropriate? Are there algorithms or decision guidelines which have
proven successful in ensuring adequate financial assurance; should EPA
adopt these guidelines as guidance or in regulation for corrective
action financial assurance? How should financial capability enter into
decisions on stabilization or corrective measures? How well is the
current financial assurance for corrective action program working? EPA
is interested in alternative approaches to ensuring the completion of
corrective actions. For example, are there particular state rules which
have proven effective in dealing with both financially sound and
financially weak firms? Are there other clean up programs which address
financial assurance more effectively than the current corrective action
program? Should evidence of corporate commitments to cleanups such as
continuing construction and progress affect financial assurance
requirements? If so, how?
(d) Cost estimates. EPA requests that commenters address the
accuracy and timing of FACA cost estimates. EPA is interested in
comments which address the causes for differences among FACA estimates
at various stages in the corrective action process, differences between
estimates and actual figures, particular stages of the corrective
action process which are more prone to cost errors than others, the
time period over which cost estimates are most accurate, and the
relationship between costs reported to permitting authorities and costs
reported in financial reports. Some permittees have suggested that cost
estimates cover only a period of two to three years with annual
updates. Would this be adequate and appropriate?
(e) Discounting. EPA requests that commenters address the use of
discounting in the FACA process. For example, would discounting produce
better estimates of corrective action costs or change corrective action
decisions? If commenters believe discounting is appropriate, the Agency
requests that comments address the effect of discounting on FACA
instruments, appropriate discount factors and time frames and, if
discounting is used, the bases for requiring or not requiring FACA for
the whole process.
(f) Use of the 1986 Proposal As Guidance. EPA requests that
commenters provide information on when the 1986 proposal has been
useful as guidance. Have the mechanisms in the proposal provided for
clean ups or clean up activities which would not have occurred without
them? Have the mechanisms or requirements diverted resources from
actual clean up activities? Are the proposal mechanisms unnecessary,
insufficient, or outdated?
J. State Authorization
EPA requests comments on general issues associated with state
authorization for corrective action and the relative roles of state and
Federal agencies in authorized states. EPA is particularly interested
in comments which address:
(a) Rate and pace of authorization. EPA intends for states to be
the primary implementors of the RCRA program. Although 49 states and
territories are authorized to implement the RCRA program, many of these
states are also authorized for significant amendments to the RCRA
program, including 29 states which are authorized for corrective
action. EPA requests comments on incentives (and disincentives) to
corrective action authorization and suggestions for improving the
efficiency of authorization processes.
(b) Role of EPA in authorized states. As more states become
authorized, EPA's role is changing. For example, in many states EPA is
doing much less direct program implementation. EPA is interested in
defining its role in authorized states and in developing oversight
models which use state and Federal resources most efficiently (e.g.,
focus on results, rather than process).
(c) Effect of promulgation of corrective action rules on authorized
state programs. Final corrective action regulations will be promulgated
pursuant to HSWA. Ordinarily, more stringent HSWA rules are immediately
effective in authorized states (RCRA Section 3006(g)(1). However, EPA
is concerned about potential disruptions to ongoing cleanup being
conducted pursuant to authorized state corrective action programs and
does not want authorized state corrective action programs to revert
back to EPA. Therefore, in 1990, EPA proposed that any revisions to
final Subpart S corrective action regulations would not become
effective in states authorized for Subpart S until those states had
adopted the new rules. Currently 29 states are authorized for the
existing corrective action regulations, EPA believes the same logic
that led it to propose that revisions to the corrective action
regulations proposed in 1990 would not become effective in authorized
states until states adopted them could arguably be applied to the
current situation; therefore, EPA requests comments on whether final
corrective action regulations should not be effective in states
authorized for the existing corrective action program until those
states adopt the final rules. EPA also requests comments on approaches
to authorization which will minimize disruption of existing state
corrective action programs upon promulgation of new Federal corrective
action requirements.
Dated: April 12, 1996.
Carol M. Browner,
Administrator.
[FR Doc. 96-9707 Filed 4-30-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-10840 Food Standards of Identity, Quality and Fill of Container; Common or Usual Name Regulations; Request for Comments on Existing Regulations
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Page 19220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10840]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 102, 130, 131, 133, 135, 136, 137, 139, 145, 146, 150,
152, 155, 156, 158, 160, 161, 163, 164, 165, 166, 168, and 169
[Docket No. 95N-0294]
Food Standards of Identity, Quality and Fill of Container; Common
or Usual Name Regulations; Request for Comments on Existing Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking; extension of comment
period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that,
while the comment period on the advance notice of proposed rulemaking
that appeared in the Federal Register of December 29, 1995 (60 FR
67492), will end on April 29, 1996, the agency will keep the record
open to receive comments on one aspect of this rulemaking. The agency
is taking this action in response to several requests for an extension
to allow comments on the issue of harmonization of the food standards
of FDA and those of the Food Safety and Inspection Service (FSIS) of
the U.S. Department of Agriculture.
DATES: Written comments by June 28, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Felicia Satchell, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 29,
1995 (60 FR 67492), FDA issued an advance notice of proposed rulemaking
entitled ``Food Standards of Identity, Quality and Fill of Container;
Common or Usual Name Regulations; Request for Comments on Existing
Regulations.'' Interested persons were given until April 29, 1996, to
comment on aspects of the advance notice of proposed rulemaking on food
standards that the agency published in December 1995.
FDA received several requests for an extension of the comment
period to allow comments on the issue of harmonization of food
standards issued by FDA and FSIS. After careful consideration, FDA has
decided to extend the comment period to June 28, 1996, on this issue.
The extension is only for this aspect of the rulemaking. The issue of
harmonization was discussed in section V.A.8. FDA-FSIS Harmonization,
found on page 67502 of the advance notice.
Interested persons may, on or before June 28, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
Dated: April 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-10840 Filed 4-26-96; 4:15 pm]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-10831 General Accounting Office, Administrative Practice and Procedure, Bid Protest Regulations, Government Contracts
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19205-19211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10831]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 /
Proposed Rules
[[Page 19205]]
GENERAL ACCOUNTING OFFICE
4 CFR Part 21
General Accounting Office, Administrative Practice and Procedure,
Bid Protest Regulations, Government Contracts
AGENCY: General Accounting Office.
ACTION: Proposed rule.
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SUMMARY: The General Accounting Office (GAO) is proposing to revise its
Bid Protest Regulations to implement the requirement in the National
Defense Authorization Act for Fiscal Year 1996 that GAO, for new
protests filed on or after August 8, 1996, issue bid protest decisions
within 100 calendar days from the time a protest is filed at GAO. The
proposed revision will facilitate GAO's meeting the new statutory
deadline for issuing bid protest decisions and will improve the overall
effectiveness of the bid protest process at GAO.
DATES: Comments must be submitted on or before July 1, 1996.
ADDRESSES: Comments should be addressed to: Michael R. Golden,
Assistant General Counsel, General Accounting Office, 441 G Street,
NW., Washington, DC 20548.
FOR FURTHER INFORMATION CONTACT: Michael R. Golden (Assistant General
Counsel) or Linda S. Lebowitz (Senior Attorney), 202-512-9732.
SUPPLEMENTARY INFORMATION: On February 21, 1996, the General Accounting
Office (GAO) published an advance notice of proposed rulemaking (61 FR
6579) soliciting comments on how its bid protest procedures could be
revised in order to facilitate GAO's meeting a new statutory deadline
for issuing bid protest decisions, while also improving the overall
effectiveness of the bid protest process at GAO. In this regard, the
National Defense Authorization Act for Fiscal Year 1996, Pub. L. 104-
106, 110 Stat. 186, which was enacted on February 10, 1996, requires
GAO, effective August 8, 1996, to issue bid protest decisions within
100 calendar days from the time a protest is filed at GAO, shortening
the current 125-calendar-day requirement. (Any further reference to
``days'' means ``calendar days.'') In the advance notice, GAO
specifically invited comments on changing its longstanding timeliness
rule to permit the filing of a protest 5 days after a statutorily
required debriefing, and on the feasibility of promoting early document
production in appropriate cases to facilitate the expeditious
resolution of bid protests. GAO also invited the submission of ideas
regarding the appropriate length of regulatorily imposed deadlines, as
well as suggestions concerning the use of accelerated or alternative
procedures to more expeditiously resolve bid protests.
Interested persons were invited to submit comments on GAO's advance
notice by March 22, 1996. We received written comments from 10 Federal
agencies, 2 bar associations, 2 law firms, 1 industry association, and
2 vendors. In preparing this proposed rule, we have carefully
considered all comments received. The commenters generally recognized
the effectiveness of our previous efforts to streamline the bid protest
process at GAO and to provide meaningful relief to vendors wrongfully
excluded from procurements, as reflected in the final rule published on
August 10, 1995 (60 FR 40737) and effective October 1, 1995. The
commenters made suggestions on how GAO could improve the internal
management of the bid protest process. While we are adopting many of
the suggested management practices and we expect to implement others in
the near future, we believe that regulatory implementation of such
improvements is unnecessary. For example, we are focusing on promptly
resolving early requests for partial or complete dismissals of
protests. We are also establishing procedures to routinely issue
protective orders, where warranted, shortly after a protest is filed.
Significant proposed revisions to GAO's Bid Protest Regulations are
set forth below.
Statutorily Imposed Deadlines
In accordance with sec. 5501 of the National Defense Authorization
Act for Fiscal Year 1996, GAO proposes to revise paragraph (c) of
Sec. 21.3 to require a contracting agency to file its report in
response to a protest with GAO within 30 days, as opposed to 35 days,
after receiving telephone notice of the protest from GAO. GAO also
proposes to revise paragraph (a) of Sec. 21.9 to require our Office to
issue a decision on a bid protest within 100 days after the protest is
filed with our Office.
Timeliness Rules
Consistent with the suggestion of several commenters, GAO's
proposed regulation at Sec. 21.2(a)(2) requires that protests, except
those alleging a solicitation impropriety, filed under a procurement in
which a debriefing is required by law be filed not later than 5 days
after the debriefing; in all other cases, the protest is required to be
filed within 10 days after the basis of protest is known or should have
been known, whichever is earlier. (Wherever possible throughout this
proposed rule in the interests of simplification and user-friendliness,
GAO proposes to establish filing times using multiples of ``five''
days. For example, GAO has reduced the ``knew/should have known''
timeliness rule from 14 days to 10 days.) GAO believes that this
proposed change to the timeliness rule will help to ensure the prompt
and fair resolution of bid protests.
Consistent with the suggestion of several commenters, GAO proposed
to add a new paragraph (a)(4) to Sec. 21.2 which reduces the time for
filing supplemental or amended protests from 14 days (pursuant to the
current ``knew/should have known'' timeliness rule) to 5 days after the
basis of protest is known or should have been known, whichever is
earlier. GAO believes that this shortening of time will permit GAO to
issue a consolidated decision resolving the supplemental or amended
protests, usually based on information provided with the agency report,
within the original 100-day period, thus avoiding rollover situations
or the issuance of separate decisions.
In paragraph (a)(3) of Sec. 21.2, GAO proposes to shorten the time
for filing a protest based on initial adverse agency action on an
agency-level protest from 14 days to 5 days. GAO agrees with those
commenters who suggested this proposed revision, recognizing that in
cases where there has been an agency-level protest, the protest issues
are usually already developed.
[[Page 19206]]
Early Document Production
In paragraph (d)(2) of Sec. 21.1, GAO proposes to add language
requiring a protester to explain the relevancy of specifically
requested documents to its protest grounds.
GAO received numerous comments concerning early document production
as a means of facilitating the prompt resolution of bid protests. As
previously addressed in the final rule at 60 FR 40737, 40738, while GAO
believes that early document production will promote the expeditious
resolution of appropriate bid protests and will result in other system
efficiencies, GAO also believes that early document production should
be accomplished on a voluntary basis, with an agency assessing the
value of such a procedure in a particular case. In this regard, in
paragraph (c) of Sec. 21.3, GAO proposes to explicitly recognize that
documents may be provided prior to the filing of the agency report or
may otherwise be made available to the parties, such as by allowing
parties to review documents on site at the agency prior to the filing
of the report.
GAO also proposes to add to paragraph (c) of Sec. 21.3 a
requirement that 5 days prior to the filing of the agency report, in
cases in which the protester has filed a request for specific
documents, that the agency provide to all parties and GAO a list of
those documents, or portions of documents, which the agency has
released to the protester or intends to produce in its report, and
those documents which the agency intends to withhold from the protester
and the reasons for the proposed withholding. GAO further proposes to
require that any objection to the scope of an agency's proposed
disclosure or nondisclosure of documents be filed with GAO and the
other parties within 1 day of receipt of this list.
Throughout Sec. 21.3, GAO proposes to clarify the language to
reflect the current longstanding practice that parties need not provide
entire documents if only certain portions of these documents are
relevant to the protest.
Several commenters expressed concern that in light of the shortened
timeframe for resolving bid protests, unsolicited submissions after the
filing of comments on the agency report or hearing are particularly
inappropriate. GAO proposes to address this concern by adding a
sentence to the proposed Sec. 21.3(j), currently at Sec. 21.3(i), which
states that the agency and other participating parties shall not submit
any additional statements unless the statements are specifically
requested by GAO or submitted after permission has been granted by GAO.
Other Regulatorily Imposed Deadlines
To facilitate meeting the shortened statutory deadline for issuing
bid protest decisions, GAO also proposes to reduce the following filing
periods: in the proposed Sec. 21.3(g), currently at Sec. 21.3(f), the
agency must respond to supplemental document requests within 2 days, as
opposed to 5 days; in the proposed Sec. 21.3(h), currently at
Sec. 21.3(g), when withheld documents are furnished, the protester's
comments on the agency report are due within the original comment
filing period, not 10 days after its receipt of the additional
documents, unless GAO specifically grants an extension; and in the
proposed Sec. 21.3(i), currently at Sec. 21.3(h), comments on the
agency report are due within 10 days, as opposed to 14 days, after
receipt of the report unless GAO specifically grants an extension. In
paragraph (b) of Sec. 21.14, GAO proposes to shorten the time for
filing requests for reconsideration (the resolution of such requests
are not subject to statutory deadlines) from 14 days to 10 days.
Accelerated or Alternative Procedures
Many commenters suggested that GAO promote the use of flexible
alternative procedures to expedite the resolution of bid protests.
Paragraph (e) of Sec. 21.10 already contains language allowing for the
establishment of accelerated schedules and the issuance of summary
decisions. In paragraph (e) of Sec. 21.10, GAO proposes to add language
specifically acknowledging that flexible alternative procedures may be
used to promptly and fairly resolve bid protests. In response to
numerous comments, GAO also proposes to add a new paragraph (f) to
Sec. 21.10, providing that GAO may conduct status conferences, by
telephone or in person, with all parties participating in the protest
to promote the expeditious development and resolution of the protest.
Miscellaneous Matters
GAO proposes to revise paragraph (e) of Sec. 21.0 in accordance
with the statutory requirement under 31 U.S.C. 3555(b) that GAO
prescribe procedures for the computation of days for all periods
described in Subchapter V, Chapter 35 of Title 31, United States Code.
In paragraph (a) of Sec. 21.3, and in response to one commenter's
suggestion, GAO proposes that all protest communications be sent by
means reasonably calculated to effect ``expeditious'' delivery,
clarifying what was intended by our previous use of ``timely''
delivery.
For annual reporting purposes, GAO proposes to add language to the
proposed Sec. 21.3(d), currently at Sec. 21.3(c), requiring agencies to
include a ``best estimate'' of the value of goods and services being
procured.
GAO proposes to remove the substantive content of paragraph (d) of
Sec. 21.5 addressing procurements protested to the General Services
Administration Board of Contract Appeals, see sec. 5101 of the National
Defense Authorization Act for Fiscal Year 1996, and proposes to replace
the substantive content with a new dismissal ground regarding the
violation of sec. 27 of the Office of Federal Procurement Policy (OFPP)
Act, 41 U.S.C. 423. Specifically, as proposed, Sec. 21.5(d) provides
that for any Federal procurement, GAO will not review an alleged
violation of subsections (a), (b), (c), and (d) of sec. 27 of the OFPP
Act, as amended by sec. 4304 of the National Defense Authorization Act
for Fiscal Year 1996, if the protester failed to report to the Federal
agency responsible for the procurement the information the protester
believes constitutes evidence of the offense within 14 days after the
protester first discovered the possible violation.
Comments
Comments concerning the proposed rule should reference file number
B-259187.2. Comments may be filed by hand delivery or mail at the
address in the address line, or by facsimile transmission at 202-512-
9749.
List of Subjects in 4 CFR Part 21
Administrative practice and procedure, Bid protest regulations,
Government contracts.
For the reasons set out in the preamble, Title 4, Chapter I,
Subchapter B, of the Code of Federal Regulations is proposed to be
amended to read as follows:
1. Part 21 is revised to read as follows:
PART 21--BID PROTEST REGULATIONS
Sec.
21.0 Definitions.
21.1 Filing a protest.
21.2 Time for filing.
21.3 Notice of protest, submission of agency report, and time for
filing of comments on report.
21.4 Protective orders.
21.5 Protest issues not for consideration.
21.6 Withholding of award and suspension of contract performance.
21.7 Hearings.
21.8 Remedies.
[[Page 19207]]
21.9 Time for decision by GAO.
21.10 Express options, flexible alternative procedures, accelerated
schedules, summary decisions, and status conferences.
21.11 Effect of judicial proceedings.
21.12 Distribution of decisions.
21.13 Nonstatutory protests.
21.14 Request for reconsideration.
Authority: 31 U.S.C. 3551-3556.
Sec. 21.0 Definitions.
(a) Interested party means an actual or prospective bidder or
offeror whose direct economic interest would be affected by the award
of a contract or by the failure to award a contract.
(b) Intervenor means an awardee if the award has been made or, if
no award has been made, all bidders or offerors who appear to have a
substantial prospect of receiving an award if the protest is denied.
(c) Federal agency means any executive department or independent
establishment in the executive branch, including any wholly owned
government corporation, and any establishment in the legislative or
judicial branch, except the Senate, the House of Representatives, and
the Architect of the Capitol and any activities under his direction.
(d) Contracting agency means a Federal agency which has awarded or
proposes to award a contract under a protested procurement.
(e) Days are calendar days. In computing any period of time
described in Subchapter V, Chapter 35 of Title 31, United States Code,
including those described in this part, the day from which the period
begins to run is not counted, and when the last day of the period is a
Saturday, Sunday, or Federal holiday, the period extends to the next
day that is not a Saturday, Sunday, or Federal holiday. Similarly, when
the General Accounting Office (GAO), or another Federal agency where a
submission is due, is closed for all or part of the last day, the
period extends to the next day on which the agency is open.
(f) Adverse agency action is any action or inaction by a
contracting agency which is prejudicial to the position taken in a
protest filed with the agency, including a decision on the merits of a
protest; the opening of bids or receipt of proposals, the award of a
contract, or the rejection of a bid despite a pending protest; or
contracting agency acquiescence in continued and substantial contract
performance.
(g) A document is filed on a particular day when it is received by
GAO by 5:30 p.m., eastern time, on that day. A document may be filed by
hand delivery, mail, or commercial carrier; parties wishing to file a
document by facsimile transmission or other electronic means must
ensure that the necessary equipment is operational at GAO's Procurement
Law Control Group.
Sec. 21.1 Filing a protest.
(a) An interested party may protest a solicitation or other request
by a Federal agency for offers for a contract for the procurement of
property or services; the cancellation of such a solicitation or other
request; an award or proposed award of such a contract; and a
termination of such a contract, if the protest alleges that the
termination was based on improprieties in the award of the contract.
(b) Protests must be in writing and addressed as follows: General
Counsel, General Accounting Office, 441 G Street, NW., Washington, DC
20548, Attention: Procurement Law Control Group.
(c) A protest filed with GAO shall:
(1) Include the name, address, and telephone and facsimile numbers
of the protester,
(2) Be signed by the protester or its representative,
(3) Identify the contracting agency and the solicitation and/or
contract number,
(4) Set forth a detailed statement of the legal and factual grounds
of protest including copies of relevant documents,
(5) Set forth all information establishing that the protester is an
interested party for the purpose of filing a protest,
(6) Set forth all information establishing the timeliness of the
protest,
(7) Specifically request a ruling by the Comptroller General of the
United States, and
(8) State the form of relief requested.
(d) In addition, a protest filed with GAO may:
(1) Request a protective order,
(2) Request specific documents, explaining the relevancy of the
documents to the protest grounds, and
(3) Request a hearing, explaining the reason that a hearing is
needed to resolve the protest.
(e) The protester shall furnish a complete copy of the protest,
including all attachments, to the individual or location designated by
the contracting agency in the solicitation for receipt of protests, or
if there is no designation, to the contracting officer. The designated
individual or location (or, if applicable, the contracting officer)
must receive a complete copy of the protest and all attachments no
later than 1 day after the protest is filed with GAO. The protest
document must indicate that a complete copy of the protest and all
attachments are being furnished within 1 day to the appropriate
individual or location.
(f) No formal briefs or other technical forms of pleading or motion
are required. Protest submissions should be concise and logically
arranged, and should clearly state legally sufficient grounds of
protest. Protests of different procurements should be separately filed.
(g) Unless precluded by law, GAO will not withhold material
submitted by a protester from any party outside the government. If the
protester believes that the protest contains information which should
be withheld, a statement advising of this fact must be on the front
page of the submission. This information must be identified wherever it
appears, and the protester must file, within 1 day after the filing of
its protest with GAO, a redacted copy of the protest which omits the
information.
(h) Parties who intend to file documents containing classified
information should notify GAO in advance to obtain advice regarding
procedures for filing and handling the information.
(i) A protest may be dismissed for failure to comply with any of
the requirements of this section, except for the items in paragraph (d)
of this section. In addition, a protest shall not be dismissed for
failure to comply with paragraph (e) of this section where the
contracting officer has actual knowledge of the basis of protest, or
the agency, in the preparation of its report, was not prejudiced by the
protester's noncompliance.
Sec. 21.2 Time for filing.
(a)(1) Protests based upon alleged improprieties in a solicitation
which are apparent prior to bid opening or the time set for receipt of
initial proposals shall be filed prior to bid opening or the time set
for receipt of initial proposals. In procurements where proposals are
requested, alleged improprieties which do not exist in the initial
solicitation but which are subsequently incorporated into the
solicitation must be protested not later than the next closing time for
receipt of proposals following the incorporation.
(2) Except for protests covered by paragraph (a)(1) of this
section, protests filed by a party that has received a debriefing
required by law shall be filed not later than 5 days after the
debriefing, and in all other cases, not later than 10 days after the
basis of protest is known or should have been known, whichever is
earlier.
(3) If a timely agency-level protest was previously filed, any
subsequent protest to GAO filed within 5 days of actual or
[[Page 19208]]
constructive knowledge of initial adverse agency action will be
considered, provided the agency-level protest was filed in accordance
with paragraphs (a)(1) and (a)(2) of this section, unless the
contracting agency imposes a more stringent time for filing, in which
case the agency's time for filing will control. In cases where an
alleged impropriety in a solicitation is timely protested to a
contracting agency, any subsequent protest to GAO will be considered
timely if filed within the 5-day period provided by this paragraph,
even if filed after bid opening or the closing time for receipt of
proposals.
(4) Protests which supplement or amend a previously filed protest
shall be filed not later than 5 days after the basis of protest is
known or should have been known, whichever is earlier.
(b) Protests untimely on their face may be dismissed. A protester
shall include in its protest all information establishing the
timeliness of the protest; a protester will not be permitted to
introduce for the first time in a request for reconsideration
information necessary to establish that the protest was timely.
(c) GAO, for good cause shown, or where it determines that a
protest raises issues significant to the procurement system, may
consider an untimely protest.
Sec. 21.3 Notice of protest, submission of agency report, and time for
filing of comments on report.
(a) GAO shall notify the contracting agency by telephone within 1
day after the filing of a protest, and, unless the protest is dismissed
under this part, shall promptly send a written confirmation to the
contracting agency and an acknowledgment to the protester. The
contracting agency shall immediately give notice of the protest to the
contractor if award has been made or, if no award has been made, to all
bidders or offerors who appear to have a reasonable prospect of
receiving an award. The contracting agency shall furnish copies of the
protest submissions to those parties, except where disclosure of the
information is prohibited by law, with instructions to communicate
further directly with GAO. All parties shall furnish copies of all
protest communications to the contracting agency and to other
participating parties. All protest communications shall be sent by
means reasonably calculated to effect expeditious delivery.
(b) A contracting agency or intervenor which believes that the
protest or specific protest allegations should be dismissed before
submission of an agency report should file a request for dismissal as
soon as practicable.
(c) The contracting agency shall file a report on the protest with
GAO within 30 days after the telephone notice of the protest from GAO.
The report provided to the parties need not contain documents which the
agency has previously furnished or otherwise made available to the
parties in response to the protest. Five days prior to the filing of
the report, in cases in which the protester has filed a request for
specific documents, the agency shall provide to all parties and GAO a
list of those documents, or portions of documents, which the agency has
released to the protester or intends to produce in its report, and the
documents which the agency intends to withhold from the protester and
the reason for the proposed withholding. Any objection to the scope of
the agency's proposed disclosure or nondisclosure of documents must be
filed with GAO and the other parties within 1 day of receipt of this
list.
(d) The report shall include the contracting officer's statement of
the relevant facts, including a best estimate of the acquisition's
value, a memorandum of law, and a list and a copy of all relevant
documents, or portions of documents, not previously produced,
including, as appropriate: the protest; the bid or proposal submitted
by the protester; the bid or proposal of the firm which is being
considered for award, or whose bid or proposal is being protested; all
evaluation documents; the solicitation, including the specifications;
the abstract of bids or offers; and any other relevant documents. In
appropriate cases, the contracting agency may request that the
protester produce relevant documents, or portions of documents, that
are not in the agency's possession.
(e) Subject to any protective order issued in the protest pursuant
to Sec. 21.4, the contracting agency shall simultaneously furnish a
copy of the report to the protester and any intervenors. The copy of
the report filed with GAO shall list the parties who have been
furnished copies of the report. Where a protester does not have counsel
admitted to a protective order and documents are withheld from the
protester in accordance with this part, the agency shall provide
documents adequate to inform the protester of the basis of the agency's
position.
(f) The contracting agency may request an extension of time for the
submission of the agency report. Extensions will be granted on a case-
by-case basis.
(g) The protester may request additional documents when their
existence or relevance first becomes evident. Except when authorized by
GAO, any request for additional documents must be filed with GAO and
the contracting agency not later than 2 days after their existence or
relevance is known or should have been known, whichever is earlier. The
contracting agency shall provide the requested documents, or portions
of documents, and a list to GAO and the other parties within 2 days or
explain why it is not required to produce the documents.
(h) Upon the request of a party, GAO will decide whether the
contracting agency must provide any withheld documents, or portions of
documents, and whether this should be done under a protective order.
When withheld documents are provided, the protester's comments on the
agency report shall be filed within the original comment filing period
unless GAO determines that an extension is appropriate.
(i) Comments on the agency report shall be filed with GAO within 10
days after receipt of the report, with a copy provided to the
contracting agency and other participating parties. The protest shall
be dismissed unless the protester files comments or a written statement
requesting that the case be decided on the existing record, or requests
an extension of time within the 10-day period. Unless otherwise advised
by the protester, GAO will assume the protester received the agency
report by the due date specified in the acknowledgment of protest
furnished by GAO. Upon a showing that the specific circumstances of a
protest require a period longer than 10 days for the submission of
comments, GAO will set a new date for the submission of comments.
Extensions will be granted on a case-by-case basis.
(j) GAO may request or permit the submission of additional
statements by the parties and by other parties not participating in the
protest as may be necessary for the fair resolution of the protest. The
agency and other participating parties shall not submit any additional
statements unless the statements are specifically requested by GAO or
submitted after permission has been granted by GAO.
Sec. 21.4 Protective orders.
(a) At the request of a party or on its own initiative, GAO may
issue a protective order controlling the treatment of protected
information. Such information may include proprietary, confidential, or
source-selection-sensitive material, as well as other information the
release of which
[[Page 19209]]
could result in a competitive advantage to one or more firms. The
protective order shall establish procedures for application for access
to protected information, identification and safeguarding of that
information, and submission of redacted copies of documents omitting
protected information. Because a protective order serves to facilitate
the pursuit of a protest by a protester through counsel, it is the
responsibility of protester's counsel to request that a protective
order be issued and to submit timely applications for admission under
that order.
(b) If no protective order has been issued, the agency may withhold
from the parties those portions of its report which would ordinarily be
subject to a protective order. GAO will review in camera all
information not released to the parties.
(c) After a protective order has been issued, counsel or
consultants retained by counsel appearing on behalf of a party may
apply for admission under the order by submitting an application to
GAO, with copies furnished simultaneously to all parties. The
application shall establish that the applicant is not involved in
competitive decision-making for any firm that could gain a competitive
advantage from access to the protected information and that there will
be no significant risk of inadvertent disclosure of protected
information. Objections to an applicant's admission shall be raised
within 2 days after receipt of the application, although GAO may
consider objections raised after that time.
(d) Any violation of the terms of a protective order may result in
the imposition of such sanctions as GAO deems appropriate, including
referral to appropriate bar associations or other disciplinary bodies
and restricting the individual's practice before GAO.
Sec. 21.5 Protest issues not for consideration.
GAO shall summarily dismiss a protest or specific protest
allegations that do not state a valid basis for protest, are untimely
(unless considered pursuant to Sec. 21.2(c)), or are not properly
before GAO. A protest or specific protest allegations may be dismissed
any time sufficient information is obtained by GAO warranting
dismissal. Where an entire protest is dismissed, no agency report shall
be filed; where specific protest allegations are dismissed, an agency
report shall be filed on the remaining allegations. Among the protest
bases which shall be dismissed are the following:
(a) Contract administration. The administration of an existing
contract is within the discretion of the contracting agency. Disputes
between a contractor and the agency are resolved pursuant to the
disputes clause of the contract and the Contract Disputes Act of 1978.
41 U.S.C. 601-613.
(b) Small Business Administration issues.--(1) Small business size
standards and standard industrial classification. Challenges of
established size standards or the size status of particular firms, and
challenges of the selected standard industrial classification may be
reviewed solely by the Small Business Administration. 15 U.S.C.
637(b)(6).
(2) Small Business Certificate of Competency Program. Any referral
made to the Small Business Administration pursuant to sec. 8(b)(7) of
the Small Business Act, or any issuance of, or refusal to issue, a
certificate of competency under that section will not be reviewed by
GAO absent a showing of possible bad faith on the part of government
officials or a failure to consider vital information bearing on the
firm's responsibility. 15 U.S.C. 637(b)(7).
(3) Procurements under sec. 8(a) of the Small Business Act. Under
that section, since contracts are entered into with the Small Business
Administration at the contracting officer's discretion and on such
terms as are agreed upon by the procuring agency and the Small Business
Administration, the decision to place or not to place a procurement
under the 8(a) program is not subject to review absent a showing of
possible bad faith on the part of government officials or that
regulations may have been violated. 15 U.S.C. 637(a).
(c) Affirmative determination of responsibility by the contracting
officer. Because the determination that a bidder or offeror is capable
of performing a contract is based in large measure on subjective
judgments which generally are not readily susceptible of reasoned
review, an affirmative determination of responsibility will not be
reviewed absent a showing of possible bad faith on the part of
government officials or that definitive responsibility criteria in the
solicitation were not met.
(d) Procurement integrity. For any Federal procurement, GAO will
not review an alleged violation of subsections (a), (b), (c), or (d) of
sec. 27 of the Office of Federal Procurement Policy Act, 41 U.S.C. 423,
as amended by sec. 4304 of the National Defense Authorization Act for
Fiscal Year 1996, Pub. L. 104-106, 110 Stat. 186, February 10, 1996,
where the protester failed to report the information it believed
constituted evidence of the offense to the Federal agency responsible
for the procurement within 14 days after the protester first discovered
the possible violation.
(e) Protests not filed either in GAO or the contracting agency
within the time limits set forth in Sec. 21.2.
(f) Protests which lack a detailed statement of the legal and
factual grounds of protest as required by Sec. 21.1(c)(4), or which
fail to clearly state legally sufficient grounds of protest as required
by Sec. 21.1(f).
(g) Procurements by agencies other than Federal agencies as defined
by sec. 3 of the Federal Property and Administrative Services Act of
1949, 40 U.S.C. 472. Protests of procurements or proposed procurements
by agencies such as the U.S. Postal Service, the Federal Deposit
Insurance Corporation, and nonappropriated fund activities are beyond
GAO's bid protest jurisdiction as established in 31 U.S.C. 3551-3556.
(h) Subcontract protests. GAO will not consider a protest of the
award or proposed award of a subcontract except where the agency
awarding the prime contract has requested in writing that subcontract
protests be decided pursuant to Sec. 21.13.
Sec. 21.6 Withholding of award and suspension of contract performance.
Where a protest is filed with GAO, the contracting agency may be
required to withhold award and to suspend contract performance. The
requirements for the withholding of award and the suspension of
contract performance are set forth in 31 U.S.C. 3553 (c) and (d).
Sec. 21.7 Hearings.
(a) At the request of a party or on its own initiative, GAO may
conduct a hearing in connection with a protest. The request shall set
forth the reasons why a hearing is needed.
(b) Prior to the hearing, GAO may hold a pre-hearing conference to
discuss and resolve matters such as the procedures to be followed, the
issues to be considered, and the witnesses who will testify.
(c) Hearings generally will be conducted as soon as practicable
after receipt by the parties of the agency report and relevant
documents. Although hearings ordinarily will be conducted at GAO in
Washington, DC, hearings may, at the discretion of GAO, be conducted at
other locations, or by telephone.
(d) All parties participating in the protest shall be invited to
attend the hearing. Others may be permitted to
[[Page 19210]]
attend as observers and may participate as allowed by GAO's hearing
official. In order to prevent the improper disclosure of protected
information at the hearing, GAO's hearing official may restrict
attendance during all or part of the proceeding.
(e) Hearings shall normally be recorded and/or transcribed. If a
recording and/or transcript is made, any party may obtain copies at its
own expense.
(f) If a witness whose attendance has been requested by GAO fails
to attend the hearing or fails to answer a relevant question, GAO may
draw an inference unfavorable to the party for whom the witness would
have testified.
(g) If a hearing is held, no separate comments on the agency report
should be submitted unless specifically requested by GAO. Each party
shall file with GAO, within 5 days after the hearing was held or as
specified by GAO, a single document expressing any comments on both the
hearing and agency report, with copies furnished to the other parties.
By the due date, if the protester has not filed comments or a written
statement requesting that the case be decided on the existing record,
GAO shall dismiss the protest.
(h) In post-hearing comments, the parties should reference all
testimony and admissions in the hearing record that they consider
relevant, providing specific citations to the testimony and admissions
referenced.
Sec. 21.8 Remedies.
(a) If GAO determines that a solicitation, cancellation of a
solicitation, termination of a contract, proposed award, or award does
not comply with statute or regulation, it shall recommend that the
contracting agency implement any combination of the following remedies:
(1) Refrain from exercising options under the contract;
(2) Terminate the contract;
(3) Recompete the contract;
(4) Issue a new solicitation;
(5) Award a contract consistent with statute and regulation; or
(6) Such other recommendation(s) as GAO determines necessary to
promote compliance.
(b) In determining the appropriate recommendation(s), GAO shall,
except as specified in paragraph (c) of this section, consider all
circumstances surrounding the procurement or proposed procurement
including the seriousness of the procurement deficiency, the degree of
prejudice to other parties or to the integrity of the competitive
procurement system, the good faith of the parties, the extent of
performance, the cost to the government, the urgency of the
procurement, and the impact of the recommendation(s) on the contracting
agency's mission.
(c) If the head of the procuring activity determines that
performance of the contract notwithstanding a pending protest is in the
government's best interest, GAO shall make its recommendation(s) under
paragraph (a) of this section without regard to any cost or disruption
from terminating, recompeting, or reawarding the contract.
(d) If GAO determines that a solicitation, proposed award, or award
does not comply with statute or regulation, it may recommend that the
contracting agency pay the protester the costs of:
(1) Filing and pursuing the protest, including attorneys' fees and
consultant and expert witness fees; and
(2) Bid and proposal preparation.
(e) If the contracting agency decides to take corrective action in
response to a protest, GAO may recommend that the agency pay the
protester the costs of filing and pursuing the protest, including
attorneys' fees and consultant and expert witness fees. The protester
shall file any request that GAO recommend that costs be paid within 15
days after being advised that the contracting agency has decided to
take corrective action. The protester shall furnish a copy of its
request to the contracting agency, which may file a response within 15
days after receipt of the request, with a copy furnished to the
protester.
(f)(1) If GAO recommends that the contracting agency pay the
protester the costs of filing and pursuing the protest and/or of bid or
proposal preparation, the protester and the agency shall attempt to
reach agreement on the amount of costs. The protester shall file its
claim for costs, detailing and certifying the time expended and costs
incurred, with the contracting agency within 90 days after receipt of
GAO's recommendation that the agency pay the protester its costs.
Failure to file the claim within that time may result in forfeiture of
the protester's right to recover its costs.
(2) The contracting agency shall issue a decision on the claim for
costs as soon as practicable after the claim is filed. If the protester
and the contracting agency cannot reach agreement within a reasonable
time, GAO may, upon request of the protester, recommend the amount of
costs the agency should pay in accordance with 31 U.S.C. 3554(c). In
such cases, GAO may also recommend that the contracting agency pay the
protester the costs of pursuing the claim for costs before GAO.
(3) The contracting agency shall notify GAO within 60 days after
GAO recommends the amount of costs the agency should pay the protester
of the action taken by the agency in response to the recommendation.
Sec. 21.9 Time for decision by GAO.
(a) GAO shall issue a decision on a protest within 100 days after
it is filed.
(b) In protests where GAO uses the express option procedures in
Sec. 21.10, GAO shall issue a decision on a protest within 65 days
after it is filed.
(c) GAO, to the maximum extent practicable, shall resolve a timely
supplemental protest adding one or more new grounds to an existing
protest, or an amended protest, within the time limit established in
paragraph (a) of this section for decision on the initial protest. If a
supplemental or an amended protest cannot be resolved within that time
limit, GAO may resolve the supplemental or amended protest using the
express option procedures in Sec. 21.10.
Sec. 21.10 Express options, flexible alternative procedures,
accelerated schedules, summary decisions, and status conferences.
(a) At the request of a party or on its own initiative, GAO may
decide a protest using an express option.
(b) The express option will be adopted at the discretion of GAO and
only in those cases suitable for resolution within 65 days.
(c) Requests for the express option shall be in writing and
received in GAO no later than 5 days after the protest or supplemental
protest is filed. GAO will promptly notify the parties whether the case
will be handled using the express option.
(d) When the express option is used, the following schedule applies
instead of those deadlines in Sec. 21.3 and Sec. 21.7:
(1) The contracting agency shall file a complete report with GAO
and the parties within 20 days after it receives notice from GAO that
the express option will be used.
(2) Comments on the agency report shall be filed with GAO and the
other parties within 5 days after receipt of the report.
(3) If a hearing is held, no separate comments on the agency report
under paragraph (d)(2) of this section should be submitted unless
specifically requested by GAO. Consolidated comments on the agency
report and hearing shall be filed within 5 days after the hearing was
held or as specified by GAO.
[[Page 19211]]
(4) Where circumstances demonstrate that a case is no longer
suitable for resolution using the express option, GAO shall establish a
new schedule for submissions by the parties.
(e) GAO may use flexible alternative procedures to promptly and
fairly resolve a protest, including establishing an accelerated
schedule and/or issuing a summary decision.
(f) GAO may conduct status conferences by telephone or in person
with all parties participating in a protest to promote the expeditious
development and resolution of the protest.
Sec. 21.11 Effect of judicial proceedings.
(a) A protester must immediately advise GAO of any court proceeding
which involves the subject matter of a pending protest and must file
with GAO copies of all relevant court documents.
(b) GAO will dismiss any protest where the matter involved is the
subject of litigation before a court of competent jurisdiction, or
where the matter involved has been decided on the merits by a court of
competent jurisdiction. GAO may, at the request of a court, issue an
advisory opinion on a bid protest issue that is before the court. In
these cases, unless a different schedule is established, the times
provided in this part for filing the agency report (Sec. 21.3(c)),
filing comments on the report (Sec. 21.3(i)), holding a hearing and
filing comments (Sec. 21.7), and issuing a decision (Sec. 21.9) shall
apply.
Sec. 21.12 Distribution of decisions.
(a) Unless it contains protected information, a copy of a decision
shall be provided to the protester, any intervenors, the head of the
contracting activity responsible for the protested procurement, and the
senior procurement executive of each Federal agency involved; a copy
shall also be made available to the public. A copy of a decision
containing protected information shall be provided only to the
contracting agency and to individuals admitted to any protective order
issued in the protest. A public version omitting the protected
information shall be prepared wherever possible.
(b) Decisions are available from GAO by electronic means.
Sec. 21.13 Nonstatutory protests.
(a) GAO will consider protests concerning awards of subcontracts by
or for a Federal agency, sales by a Federal agency, or procurements by
agencies of the government other than Federal agencies as defined in
Sec. 21.0(c) if the agency involved has agreed in writing to have
protests decided by GAO.
(b) The provisions of this part shall apply to nonstatutory
protests except for the provision of Sec. 21.8(d) pertaining to
recommendations for the payment of costs. The provision for the
withholding of award and the suspension of contract performance, 31
U.S.C. 3553 (c) and (d), also does not apply to nonstatutory protests.
Sec. 21.14 Request for reconsideration.
(a) The protester, any intervenor, and any Federal agency involved
in the protest may request reconsideration of a bid protest decision.
GAO will not consider a request for reconsideration that does not
contain a detailed statement of the factual and legal grounds upon
which reversal or modification is deemed warranted, specifying any
errors of law made or information not previously considered.
(b) A request for reconsideration of a bid protest decision shall
be filed, with copies to the parties who participated in the protest,
not later than 10 days after the basis for reconsideration is known or
should have been known, whichever is earlier.
(c) GAO will summarily dismiss any request for reconsideration that
fails to state a valid basis for reconsideration or is untimely. The
filing of a request for reconsideration does not require the
withholding of award and the suspension of contract performance under
31 U.S.C. 3553 (c) and (d).
Robert P. Murphy,
General Counsel.
[FR Doc. 96-10831 Filed 4-30-96; 8:45 am]
BILLING CODE 1610-01-P
Complete official Federal Register PDF
FR Doc. 96-10821 Drawbridge Operation Regulation; Bonfouca Bayou, LA
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19222-19224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10821]
-----------------------------------------------------------------------
[[Page 19223]]
DEPARTMENT OF TRANSPORTATION
33 CFR Part 117
[CGD8-95-026]
RIN 2115-AE47
Drawbridge Operation Regulation; Bonfouca Bayou, LA
AGENCY: Coast Guard, DOT.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: At the request of the Louisiana Department of Transportation
and Development (LDOTD), the Coast Guard is proposing a change to the
regulation governing the operation of the swing span drawbridge across
Bonfouca Bayou, mile 7.0, at Slidell, St. Tammany Parish, Louisiana.
The proposed regulation would require that from 6 a.m. to 9 a.m. and
from 3 p.m. to 6 p.m., peak vehicular traffic periods, Monday through
Friday, except Federal holidays, the draw will remain closed to
navigation. From 9 p.m. to 5 a.m. the bridge will be opened for vessel
passage if at least 12 hours notice is given. Presently, the draw is
required to open on signal; except that, from 6 a.m. to 9 a.m. and from
3 p.m. to 6 p.m., Monday through Friday except Federal holidays, the
draw opens on the hour and half hour and the draw opens on demand from
9 p.m. to 5 a.m. if at least 12 hours advance notice is given. This
change will relieve vehicular traffic congestion that has increased
dramatically during recent years, and still provide for the reasonable
needs of navigation.
DATES: Comments must be received on or before July 1, 1996.
ADDRESSES: Comments should be mailed to Commander (ob), Eighth Coast
Guard District, 501 Magazine Street, New Orleans, Louisiana 70130-3396,
or may be delivered to Room 1313 at the same address between 8:00 a.m.
and 3:00 p.m., Monday through Friday, except Federal holidays. The
telephone number is (504) 589-2965.
FOR FURTHER INFORMATION CONTACT:
Mr. Phil Johnson, Bridge Administration Branch, at the address given
above, telephone (504) 589-2965.
SUPPLEMENTARY INFORMATION:
Request for Comments
Interested parties are invited to participate in the proposed
rulemaking by submitting written views, comments, or arguments. Persons
submitting comments should include their names and addresses, identify
the bridge and give reasons for concurrence with or any recommended
change in this proposal. Persons desiring acknowledgment that their
comments have been received should enclose a stamped, self-addressed
postcard or envelope.
The Coast Guard plans no public hearing. Persons may request a
public hearing by writing to the Eighth Coast Guard District at the
address under ADDRESSES. The request should include reasons why a
hearing would be beneficial. If it determines that the opportunity for
oral presentations will aid this rulemaking, the Coast Guard will hold
a public hearing at a time and place announced by a later notice in the
Federal Register.
The Commander, Eighth Coast Guard District, will evaluate all
communications received and determine a course of final action on this
proposal. The proposal regulation may be changed in the light of
comments received.
Discussion of Proposed Rules
The present regulation requires that the bridge remain closed to
navigation from 6 a.m. to 9 a.m. and 3 p.m. to 6 p.m., Monday through
Friday except Federal holidays with the draw opening on the half hour
during these periods. The Louisiana Department of Transportation and
Development with the support of Congressman Robert L. Livingston and
many other parish and city officials, has requested the elimination of
the opening on the half hour in order to enhance vehicular traffic to
cross the bridge during the peak vehicular traffic periods. Mariners
will be able to adjust to the new closures with little or no
inconvenience.
The Bonfouca Bayou, swingspan bridge at mile 7.0, at Slidell, St.
Tammany Parish, Louisiana, has 3.5 feet vertical clearance above high
tide in the closed to navigation position and 6.7 feet above low tide
at the pivot pier, and 8.2 feet clearance above high tide and 11.4 feet
above low tide at the rest pier. Navigation on the waterway consists of
tugs with tows, fishing vessels, sailing vessels, and recreational
craft. Data provided by LDOTD show that from September 1994 through
September 1995, the number of vessels that passed the bridge during the
proposed closure periods averaged 1.8 vessels per day.
Data provided also shows that approximately 1532 vehicles cross the
bridge during the proposed 6 a.m. to 9 a.m. closure and approximately
2261 vehicles cross the bridge during the proposed 3 p.m. to 6 p.m.
closure. Delays to this amount of vehicular traffic paralyze this
section of the city for many hours.
Regulatory Evaluation
This proposal is not a significant regulatory action under section
3(f) of Executive Order 12866 and does not require an assessment of
potential cost and benefits under section 6(a)(3) of that order. It has
not been reviewed by the Office of Management and Budget under that
order. It is not significant under the regulatory policies and
procedures of the Department of Transportation (DOT) (44 FR 11040;
February 26, 1979).
The Coast Guard expects the economic impact of this proposal to be
so minimal that a full Regulatory Evaluation under paragraph 10e of the
regulatory policies and procedures of DOT is unnecessary.
Small Entities
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Coast Guard must consider whether this proposal, if adopted, will have
a significant economic impact on a substantial number of small
entities. ``Small entities'' may include (1) small businesses and not-
for-profit organizations that are independently owned and operated and
are not dominant in their fields and (2) governmental jurisdictions
with populations of less than 50,000.
Since the proposed rule also considers the needs of local
commercial fishing vessels, the economic impact is expected to be
minimal. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b)
that this proposal, if adopted, will not have a significant economic
impact on a substantial number of small entities.
Collection of Information
This proposal contains no collection-of-information requirements
under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Federalism Implications
This action has been analyzed in accordance with the principles and
criteria contained in Executive Order 12612, and it has been determined
that the proposed rulemaking does not have sufficient federalism
implications to warrant the preparation of a Federalism Assessment.
Environment
The Coast Guard considered the environmental impact of this
proposal and concluded that under paragraph 2.B.2. of Commandant
Instruction M16475.1B, this proposal is categorically excluded from
further environmental documentation. A ``Categorical Exclusion
Determination'' is available in the docket for inspection or copying
where indicated under ADDRESSES.
List of Subjects in 33 CFR Part 117
Bridges.
[[Page 19224]]
For the reasons set out in the preamble, the Coast Guard proposes
to amend part 117 of title 33, Code of Federal Regulations, as follows:
PART 117--DRAWBRIDGE OPERATION REGULATIONS
1. The authority citation for part 117 continues to read as
follows:
Authority: 33 U.S.C. 499; 49 CFR 1.46; 33 CFR 1.05-1(g); section
117.255 also issued under the authority of Pub. L. 102-587, 106
Stat. 5039.
2. Section 117.433 is revised to read as follows:
Sec. 117.433 Bonfouca Bayou.
The draw of the S433 bridge, mile 7.0, at Slidell, shall open on
signal; except that, from 9 p.m. to 5 a.m., the draw shall open on
signal if at least 12 hours notice is given. From 6 a.m. to 9 a.m. and
from 3 p.m. to 6 p.m. Monday through Friday except Federal holidays,
the draw need not be opened for the passage of vessels.
Dated: January 25, 1996.
R.C. North,
Rear Admiral, U.S. Coast Guard Commander Eighth Coast Guard District.
[FR Doc. 96-10821 Filed 4-30-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-10809 Air Quality: Revision to Definition of Volatile Organic CompoundsExclusion of HFC 43-10mee and HCFC 225ca and cb
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19231-19233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10809]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 51
[FRL-5466-9]
Air Quality: Revision to Definition of Volatile Organic
Compounds--Exclusion of HFC 43-10mee and HCFC 225ca and cb
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This action proposes to revise EPA's definition of volatile
organic compounds (VOC) for purposes of preparing State implementation
plans (SIP's) to attain the national ambient air quality standards
(NAAQS) for ozone under title I of the Clean Air Act (Act) and for the
Federal implementation plan (FIP) for the Chicago ozone nonattainment
area. This proposed revision would add HFC 43-10mee and HCFC 225ca and
cb to the list of compounds excluded from the definition of VOC on the
basis that these compounds have negligible contribution to tropospheric
ozone formation.
DATES: Comments on this proposal must be received by May 31, 1996.
Requests for a hearing must be submitted by May 31, 1996.
ADDRESSES: Comments should be submitted in duplicate (if possible) to:
Air and Radiation Docket and Information Center (6102), Attention:
Docket No. A-95-37, U.S. Environmental Protection Agency, 401 M Street,
SW., Washington, DC 20460. Comments should be strictly limited to the
subject matter of this proposal, the scope of which is discussed below.
Public Hearing: If anyone contacts EPA requesting a public hearing,
it will be held at Research Triangle Park, North Carolina. Persons
wishing to request a public hearing, wanting to attend the hearing, or
wishing to present oral testimony should notify Mr. William Johnson,
Air Quality Strategies and Standards Division (MD-15), Environmental
Protection Agency, Research Triangle Park, North Carolina 27711,
telephone (919) 541-5245. The EPA will publish notice of a hearing, if
requested, in the Federal Register. Any hearing will be strictly
limited to the subject matter of the proposal, the scope of which is
discussed below. This action is subject to the procedural requirements
of section 307(d)(1) (B), (J), and (U) of the Act, and 42 U.S.C.
Sec. 7607(d)(1) (B), (J), and (U). Therefore, EPA has established a
public docket for this action, A-95-37, which is available for public
inspection and copying between 8 a.m. and 4 p.m., Monday through
Friday, at EPA's Air and Radiation Docket and Information Center,
(6102), 401 M Street, SW., Washington, DC 20460. A reasonable fee may
be charged for copying.
FOR FURTHER INFORMATION CONTACT: William Johnson, Office of Air Quality
Planning and Standards, Air Quality Strategies and Standards Division
(MD-15), Research Triangle Park, NC 27711, phone (919) 541-5245.
Interested persons may call Mr. Johnson to see if a hearing will be
held and the date and location of any hearing.
SUPPLEMENTARY INFORMATION:
I. Background
Petitions have been received from two organizations asking for
certain compounds to be added to the list of compounds which are
considered to be negligibly reactive in the definition of VOC at 40 CFR
51.100(s). On December 12, 1994, Asahi Glass America, Inc., submitted a
petition for HCFC 225 ca and cb isomers. These compounds are chemically
named 3,3-dichloro-1,1,1,2,2-pentafluoropropane (CAS number 422-56-0)
and 1,3-dichloro-1,1,2,2,3-pentafluoropropane (CAS number 507-55-1),
respectively. On March 13, 1995, the E.I. du Pont de Nemours and
Company submitted a petition for the compound HFC 43-10mee. This
compound has the chemical name 1,1,1,2,3,4,4,5,5,5-decafluoropentane
(CAS number 138495-42-8).
In support of their petitions, these organizations supplied
information on the photochemical reactivity of the individual
compounds. This information consisted mainly of the rate constant for
the reaction of the compound with the hydroxyl (OH) radical. This rate
constant (kOH value) is commonly used as one measure of the
photochemical reactivity of compounds. The petitioners compared the
rate constants with that of other compounds which have already been
listed as photochemically, negligibly reactive (e.g., ethane which is
the compound with the highest kOH value that is currently regarded
as negligibly reactive). The compounds for which petitions were
submitted are listed in Table 1 along with their reported kOH rate
constants.
Table 1--Reaction Rate Constants with OH Radical
------------------------------------------------------------------------
Reported rate constant at 25
Compound deg.C cm\3\/molecule/sec
------------------------------------------------------------------------
Ethane................................... 2.4 x 10-13
HCFC-225ca............................... 2.5 x 10-14
HCFC-225cb............................... 8.6 x 10-15
HFC 43-10mee............................. 3.87 x 10-15
------------------------------------------------------------------------
The scientific information which the petitioners have submitted in
support of their petitions has been added to the docket for this
rulemaking. This information includes references for the journal
articles where the rate constant values are published.
II. The EPA Response to the Petitions
In regard to the petition for HCFC 225ca and HCFC 225cb, existing
data support that the reactivities of these compounds with respect to
reaction with OH radicals in the atmosphere are considerably lower than
that of ethane. This would indicate that these compounds are less
reactive than ethane which is already classified as negligibly
reactive. Similarly, for HFC 43-10mee, the rate constant of reaction
with the OH radical is considerably less than that for ethane.
In each of the above petitions, the petitioners did not submit
reactivity data with respect to other VOC loss reactions (such as
reaction with O-atoms, nitrogen trioxide (NO3)-radicals, and ozone
0(O3), and for photolysis).
[[Page 19232]]
However, there is ample evidence in the literature that halogenated
paraffinic VOC, such as these compounds, do not participate in such
reactions significantly.
The EPA is responding to these petitions by proposing, in this
notice, to add HFC 43-10mee and HCFC 225 ca and cb to the list of
compounds appearing in 40 CFR 51.100(s).
III. Final Action
Today's proposed action is based on EPA's review of the material in
Docket No. A-95-37. The EPA hereby proposes to amend its definition of
VOC at 40 CFR 51.100(s) to exclude HCFC 43-10mee, HCFC 225ca and HCFC
225cb as VOC for ozone SIP and ozone control purposes. The revised
definition will apply in the Chicago ozone nonattainment area pursuant
to the 40 CFR 52.741(a)(3) definition of volatile organic material or
VOC. States are not obligated to exclude from control as a VOC those
compounds that EPA has found to be negligibly reactive. However, if
this action is made final, States should not include these compounds in
their VOC emissions inventories for determining reasonable further
progress under the Act (e.g., section 182(b)(1)) and may not take
credit for controlling these compounds in their ozone control strategy.
IV. Administrative Requirements
A. Docket
The docket is an organized and complete file for all information
submitted or otherwise considered by EPA in the development of this
proposed rulemaking. The principle purposes of the docket are: (1) To
allow interested parties to identify and locate documents so that they
can effectively participate in the rulemaking process; and, (2) to
serve as the record in case of judicial review (except for interagency
review materials) (Section 307(d)(7)(A)).
B. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether a regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of this Executive Order. The order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligation of recipients
thereof; or
(4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is not ``significant'' because none of the
listed criteria apply to this action. Consequently, this action was not
submitted to OMB for review under Executive Order 12866.
C. Unfunded Mandates Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded
Mandates Act) (signed into law on March 22, 1995) requires that the
Agency prepare a budgetary impact statement before promulgating a rule
that includes a Federal mandate that may result in expenditure by
State, local, and tribal governments, in aggregate, or by the private
sector of $100 million or more in any 1 year. Section 204 requires the
Agency to establish a plan for obtaining input from and informing,
educating, and advising any small governments that may be significantly
or uniquely affected by the rule.
Under section 205 of the Unfunded Mandates Act, the Agency must
identify and consider a reasonable number of regulatory alternatives
before promulgating a rule for which a budgetary impact statement must
be prepared. The Agency must select from those alternatives the least
costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule, unless the Agency explains why
this alternative is not selected or the selection of this alternative
is inconsistent with law. Because this proposed rule is estimated to
result in the expenditure by State, local and tribal governments or the
private sector of less than $100 million in any 1 year, the Agency has
not prepared a budgetary impact statement or specifically addressed the
selection of the least costly, most cost-effective, or least burdensome
alternative. Because small governments will not be significantly or
uniquely affected by this rule, the Agency is not required to develop a
plan with regard to small governments.
D. Regulatory Flexibility Act
For proposed and final rules, the Regulatory Flexibility Act of
1980 requires the Agency to perform a regulatory flexibility analysis,
identifying the economic impact of the rule on small entities. 5 U.S.C.
Sec. 601 et. seq. In the alternative, if the Agency determines that the
rule will not have a significant economic impact on a substantial
number of small entities, the Agency can make a certification to that
effect. Because this rule relieves a restriction, it will not impose
any adverse economic impact on small entities. Therefore, pursuant to 5
U.S.C. Sec. 605(b), I hereby certify that this action will not have a
significant economic impact on a substantial number of small entities
because it relaxes current regulatory requirements rather than imposing
new ones.
E. Paperwork Reduction Act
This rule does not change any information collection requirements
subject to OMB under the Paperwork Reduction Act of 1980, 44 U.S.C.
3501 et seq.
List of Subjects in 40 CFR Part 51
Environmental protection, Administrative practice and procedure,
Air pollution control, Carbon monoxide, Intergovernmental relations,
Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Dated: April 25, 1996.
Carol M. Browner,
Administrator.
For reasons set forth in the preamble, part 51 of chapter I of
title 40 of the Code of Federal Regulations is proposed to be amended
as follows:
PART 51--REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF
IMPLEMENTATION PLANS
1. The authority citation for part 51 continues to read as follows:
Authority: 42 U.S.C. 7401-7641q.
2. Section 51.100 is proposed to be amended by revising paragraphs
(s) introductory text and (s)(1) introductory text to read as follows:
Sec. 51.100 Definitions.
* * * * *
(s) ``Volatile organic compounds (VOC)'' means any compound of
carbon, excluding carbon monoxide, carbon dioxide, carbonic acid,
metallic carbides or carbonates, and ammonium
[[Page 19233]]
carbonate, which participates in atmospheric photochemical reactions.
(1) This includes any such organic compound other than the
following, which have been determined to have negligible photochemical
reactivity: methane; ethane; methylene chloride (dichloromethane);
1,1,1-trichloroethane (methyl chloroform); 1,1,2-trichloro-1,2,2-
trifluoroethane (CFC-113); trichlorofluoromethane (CFC-11);
dichlorodifluoromethane (CFC-12); chlorodifluoromethane (HCFC-22);
trifluoromethane (HFC-23); 1,2-dichloro 1,1,2,2-tetrafluoroethane (CFC-
114); chloropentafluoroethane (CFC-115); 1,1,1-trifluoro 2,2-
dichloroethane (HCFC-123); 1,1,1,2-tetrafluoroethane (HFC-134a); 1,1-
dichloro 1-fluoroethane (HCFC-141b); 1-chloro 1,1-difluoroethane (HCFC-
142b); 2-chloro-1,1,1,2-tetrafluoroethane (HCFC-124); pentafluoroethane
(HFC-125); 1,1,2,2-tetrafluoroethane (HFC-134); 1,1,1-trifluoroethane
(HFC-143a); 1,1-difluoroethane (HFC-152a); parachlorobenzotrifluoride
(PCBTF); cyclic, branched, or linear completely methylated siloxanes;
acetone; perchloroethylene (tetrachloroethylene); 3,3-dichloro-
1,1,1,2,2-pentafluoropropane (HCFC-225ca); 1,3-dichloro-1,1,2,2,3-
pentaflouropropane (HCFC-225cb); 1,1,1,2,3,4,4,5,5,5-decafluoropentane
(HFC 43-10mee); and perfluorocarbon compounds which fall into these
classes:
* * * * *
[FR Doc. 96-10809 Filed 4-30-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-10804 Capsaicin, and Ammonium Salts of Fatty Acids; Proposed Tolerance Actions
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19233-19236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10804]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300422; FRL-5362-9]
RIN 2070-AB18
Capsaicin, and Ammonium Salts of Fatty Acids; Proposed Tolerance
Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: For the pesticides subject to the actions listed in this
proposed rule, EPA has completed the reregistration process and issued
a Reregistration Eligibility Decision (RED). In the reregistration
process, all information to support a pesticide's continued
registration is reviewed for adequacy and, when needed, supplemented
with new scientific studies. Based on the RED tolerance assessments for
the pesticide chemicals subject to this proposed rule, EPA is proposing
to exempt from the requirement of a tolerance, all registered food uses
for the pesticides, capsaicin and ammonium salts of fatty acids.
DATES: Written comments, identified with the docket number [OPP-300422]
should be submitted to EPA by July 1, 1996.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA. Information submitted as a
comment concerning this notice may be claimed confidential by marking
any part or all of that information as ``Confidential Business
Information'' (CBI). Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
comment(s) that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential may be disclosed
publicly by EPA without prior notice to the submitter. Any written
comments will be available for public inspection in Rm. 1132 at the
Virginia address given above, from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption.
[[Page 19234]]
Comments and data will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All comments and data in electronic
form must be identified by the docket number [OPP-300422]. No
Confidential Business Information (CBI) should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: David H. Chen, Special Review
and Reregistration Division (7508W), Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location: Special Review
Branch, Crystal Station #1, 3rd floor, 2800 Crystal Drive, Arlington,
VA 22202. Telephone: (703)-308-8017, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Legal Authorization
The Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et
seq.) authorizes the establishment of tolerances (maximum legal residue
levels) and exemptions from the requirement of a tolerance for residues
of pesticide chemicals in or on raw agricultural commodities pursuant
to section 408 [21 U.S.C. 346(a)]. Without such tolerances or
exemptions, a food containing pesticide residues is considered
``adulterated'' under section 402 of the FFDCA, and hence may not
legally be moved in interstate commerce [21 U.S.C. 342]. To establish a
tolerance or an exemption under section 408 of the FFDCA, EPA must make
a finding that the promulgation of the rule would ``protect the public
health'' [21 U.S.C. 346a(b)]. For a pesticide to be sold and
distributed, the pesticide must not only have appropriate tolerances
under the FFDCA, but also must be registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et
seq.).
In 1988, Congress amended the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.) and required EPA to
review and reassess the potential hazards arising from currently
registered uses of pesticides registered prior to November 1, 1984. As
part of this process, the Agency must determine whether a pesticide is
eligible for reregistration or whether any subsequent actions are
required to fully attain reregistration status. EPA has chosen to
include in the reregistration process a reassessment of existing
tolerances or exemptions from the need for a tolerance. Through this
reassessment process, based on more recent data, EPA can determine
whether a tolerance must be amended, revoked, or established, or
whether an exemption from the requirement of one or more tolerances
must be amended or is necessary.
The procedure for establishing, amending, or revoking tolerances or
exemptions from the requirement of tolerances is set forth in 40 CFR
parts 177 through 180. The Administrator of EPA, or any person by
petition, may initiate an action proposing to establish, amend, revoke,
or exempt a tolerance for a pesticide registered for food uses. Each
petition or request for a new tolerance, an amendment to an existing
tolerance, or a new exemption from the requirement of a tolerance must
be accompanied by a fee. Current Agency policy on tolerance actions
arising from the reregistration process is to administratively process
some actions without requiring payment of a fee; this waiver of fees
applies to revisions or revocations of established tolerances, and to
proposed exemptions from the requirement of a tolerance if the proposed
exemption requires the concurrent revocation of an established
tolerance. Comments submitted in response to the Agency's published
proposals are reviewed; the Agency then publishes its final
determination regarding the specific tolerance actions.
II. Chemical-Specific Information and Proposed Actions
A. Capsaicin: Exemption from the Requirement of a Tolerance
1. Regulatory history. Capsaicin (8-methyl-n-vanillyl-6-non) and
related capsaicinoids are the ingredients that produce the
``hotness''in certain species of peppers in the Genus Capsicum. When
used as a toxicant or repellent, products may consist simply of ground
hot peppers or as an oleoresin extracted from the ground hot peppers.
In either case, the amount of the actives must be verified by High
Performance Liquid Chromatography. Products containing capsaicin and
related capsaicinoids typically are formulated alone or in combinations
with other active ingredients, such as garlic, allyl isothiocyanate
(the active ingredient in oil of mustard), and egg solids. Formulations
include dusts, granulars, gels, aerosols, and liquids. The U.S.
Department of Agriculture first registered a product containing these
actives in 1962, as a dog-attack repellent (Reregistration Eligibility
Document for Capsaicin, Case 4018, U.S. Environmental Protection
Agency, June 1992, Page 3).
Currently, capsaicin is registered for use as an animal repellent
against attacking dogs, birds, voles, deer, rabbits, and tree
squirrels, and for use as an insect toxicant and repellent. Capsaicin
products are used indoors in crack and crevice, on carpets and
upholstered furniture, and outdoors on fruit and vegetable crops,
grains, ornamental plants and shrubs, flowers, lawns, gardens and
garbage bags. Because capsaicin is a naturally-occurring substance
which exhibits a non-toxic mode of action in humans, in 1991, EPA
reclassified capsaicin as a biochemical pesticide.
2. Current proposal. Red peppers have long been used as a food
without any known adverse health effects to man. In the absence of
known toxicological concerns from the ingestion of capsaicin and
related capsaicinoids, the Agency does not believe a tolerance for
capsaicin is needed to protect the public health. Therefore, EPA
proposes to exempt capsaicin from the requirement of a tolerance for
residues in or on fruits, vegetables, and grains.
B. Ammonium Salts of Fatty Acids: Exemptions from the Requirement of a
Tolerance
1. Regulatory history. Pesticidal products containing mineral salts
of fatty acids were first registered in 1947 (Reregistration
Eligibility Document for Soap Salts, Case 4083, U.S. Environmental
Protection Agency, September 1992). Currently, the two active
ingredients are potassium salts of fatty acids, which are registered as
insecticides, acaricides, herbicides, and algaecides, and ammonium
salts of fatty acids which are registered for use as rabbit and deer
repellent on forage and grain crops, vegetables, and field crops.
Similar to potassium salts of fatty acids, structurally, ammonium salts
are linked with naturally occurring fatty acids comprising of C8-
C18 saturated and C18 unsaturated chain lengths. Naturally
occurring fatty acids constitute a significant part of the normal daily
diet, are of low toxicity when taken orally, and pose no known health
risks. The residues of these salts of fatty acids from pesticide use
are not likely to exceed levels of naturally occurring fatty acids in
commonly eaten foods. Both potassium and ammonium salts of fatty acids
are generally recognized as safe by the Food and Drug Administration of
the Department of Health and Human Services. An exemption from the
requirement of a tolerance for all food uses already exists for
potassium salts of fatty acids (40 CFR 180.1068).
2. Current proposal. On September 10, 1980, the Thompson-Hayward
Co.
[[Page 19235]]
made a formal request to the EPA for an exemption from the requirement
of a tolerance for ammonium salts of fatty acids. The request was
reviewed by the Agency, which had no objections to the addition of food
uses. The addition of food uses was accepted in 1982. However, a formal
notice of the proposed exemption was not published in the Federal
Register. The Agency is now proposing to establish an exemption from
the requirement of a tolerance for all food uses under FFDCA section
408 for ammonium salts of fatty acids, because a tolerance is not
needed to protect the public health.
III. Public Comment Procedures
EPA invites interested parties to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by July 1, 1996. Comments must bear a notation indicating
the docket number. Three copies of the comments should be submitted to
either location listed under ADDRESSES.
Information submitted as a comment concerning this document may be
claimed confidential by marking any or all of that information as
``Confidential Business Information'' (CBI). EPA will not disclose
information so marked, except in accordance with procedures set forth
in 40 CFR part 2. A second copy of such comments, with the CBI deleted,
must also be submitted for inclusion in the public record. EPA may
publically disclose without prior notice information not marked
confidential.
Any person who has registered or submitted an application for
registration of a pesticide, under FIFRA, as amended, that contains any
of the ingredients listed herein, may request within 30 days after
publication of this notice in the Federal Register that this rulemaking
proposal be referred to an Advisory Committee in accordance with
section 408(e) of the FFDCA.
EPA has established a record for this proposed rule under docket
number [OPP-300422], (including comments submitted electronically as
described below). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8 a.m. to
4:30 p.m., Monday through Friday, except legal holidays. The public
record is located in Room 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
[email protected]
The official record for this proposed rule, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official proposed rule record which will also include all comments
submitted directly in writing. The official proposed rule record is the
paper record maintained at the ``ADDRESSES'' at the beginning of this
document.
IV. Regulatory Assessment Requirements
To satisfy requirements for analysis specified by Executive Order
12866, the Regulatory Flexibility Act, the Paperwork Reduction Act, and
the Unfunded Mandates Reform Act, EPA has considered the impacts of
this proposal.
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in a rule: (1) Having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or state, local, or tribal tribal
governments or communities (also referred to as ``economically
significant''; (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not a ``significant regulatory action,'' because it
does not meet any of the regulatory-significance criteria listed above.
B. Regulatory Flexibility Act
EPA has reviewed this proposed rule under the Regulatory
Flexibility Act of 1980 [Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et
seq.], and has determined that it will not have a significant economic
impact on any small businesses, governments, or organizations. The
proposed actions are not expected to significantly impact entities of
any size.
Accordingly, I certify that this proposed rule does not require a
separate regulatory flexibility analysis under the Regulatory
Flexibility Act.
C. Paperwork Reduction Act
This proposed regulatory action does not contain any information
collection requirements subject to review by OMB under the Paperwork
Reduction Act of 1980, 44 U.S.C. 3501 et seq.
D. Unfunded Mandates
This proposed rule contains no Federal mandates under Title II of
the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, for State,
local, or tribal governments or the private sector, because it would
not impose enforceable duties on them.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 12, 1996.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 would continue to read as
follows:
Authority: 15 U.S.C. 346a and 371.
2. Section 180.1165 is added to subpart D to read as follows:
Sec. 180.1165 Capsaicin; exemption from the requirement of a
tolerance.
Capsaicin is exempted from the requirement of a tolerance for
residues in or on fruits, vegetables, and grains, when used in
accordance with labelled rates and with good agricultural practice.
3. Section 180.1166 is added to subpart D to read as follows:
Sec. 180.1166 Ammonium salts of fatty acids; exemption from the
requrement of a tolerance.
Ammonium oleate and related C8-C18 fatty acids ammonium
salts, are exempted from the requirement of a tolerance for residues in
or on all raw agricultural commodities when used in
[[Page 19236]]
accordance with good agricultural practice.
[FR Doc. 96-10804 Filed 4-30-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-10782 Approval And Promulgation Of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; Michigan; Extension of Comment Period
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Page 19233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10782]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 52 and 81
[MI43-02-7256; AMS-FRL-5466-6]
Approval And Promulgation Of Implementation Plans and Designation
of Areas for Air Quality Planning Purposes; Michigan; Extension of
Comment Period
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking; extension of the comment period.
-----------------------------------------------------------------------
SUMMARY: The EPA is extending the comment period for a proposed action
published on April 2, 1996 (61 FR 14522) pertaining to the Grand Rapids
moderate ozone nonattainment area. On April 2, 1996, the EPA proposed
approval of Michigan's request to redesignate the Grand Rapids moderate
ozone nonattainment area to attainment for ozone and associated section
175A maintenance plan revision to the Michigan State Implementation
Plan (SIP) contingent on the State's submittal of a revision to the
maintenance plan to incorporate 3 additional control programs to the
list of contingency measures. On April 19, 1996, the EPA received a
request for an extension of the public comment period based on the fact
that the revision to the section 175A maintenance plan SIP was not
available in the EPA's docket until April 15, 1996. Since the revision
to the section 175A maintenance plan SIP revision was not available for
approximately the first two weeks of the public comment period, the EPA
is extending the comment period only on the aspects of the
redesignation and corresponding section 175A maintenance plan SIP
revision components pertaining to the State's revision to the
maintenance plan submitted on April 15, 1996 for 14 days. The public
comment period pertaining to the other components of the redesignation
request and maintenance plan SIP revision are not extended and comments
on these components are due to EPA by May 2, 1996.
DATES: Comments on the aspects of the April 2, 1996, (61 FR 14522)
proposed action on the redesignation and corresponding section 175A
maintenance plan pertaining to the State's April 15, 1996 SIP revision
must be received in writing by May 16, 1996.
FOR FURTHER INFORMATION CONTACT: Jacqueline Nwia, Environmental
Engineer, Regulation Development Section, Air Programs Branch (AR-18J),
United States Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6081.
SUPPLEMENTARY INFORMATION:
List of Subjects
40 CFR Part 52
Environmental protection, Air pollution control, Hydrocarbons,
Motor vehicle pollution, Nitrogen oxides, Ozone, Volatile organic
compounds.
40 CFR Part 81
Environmental protection, Air pollution control, National parks,
Wilderness areas.
Authority: 42 U.S.C. 7401-7671q.
Dated: April 24, 1996.
Valdas V. Adamkus,
Regional Administrator.
[FR Doc. 96-10782 Filed 4-30-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-10765 Revision of Patent Fees for Fiscal Year 1997
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19224-19231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10765]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No. 960417113-6113-01]
RIN 0651-AA82
Revision of Patent Fees for Fiscal Year 1997
AGENCY: Patent and Trademark Office, Commerce.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Patent and Trademark Office (PTO) is proposing to amend
the rules of practice in patent cases, Part 1 of title 37, Code of
Federal Regulations, to adjust certain patent fee amounts to reflect
fluctuations in the Consumer Price Index (CPI) and to recover costs of
operation.
DATES: Written comments must be submitted on or before June 5, 1996.
A public hearing will be held on Wednesday, June 5, 1996, at 9:00
a.m.
Requests to present oral testimony should be received on before
June 4, 1996.
ADDRESSES: Address written comments and requests to present oral
testimony to the Commissioner of Patents and Trademarks, Washington, DC
20231, Attention: Robert Kopson, suite 1107, Crystal Park 1, or by fax
to (703) 305-8525.
The hearing will be held in suite 912 of Crystal Park 2, located at
2121 Crystal Drive, Arlington, Virginia.
Written comments and a transcript of the hearing will be available
for public inspection in suite 1107 of Crystal Park 1, located at 2011
Crystal Drive, Arlington, Virginia.
FOR FURTHER INFORMATION CONTACT:
Robert Kopson by telephone at (703) 305-8510, fax at (703) 305-8525, or
by mail marked to his attention and addressed to the Commissioner of
Patents and Trademarks, Washington, DC 20231.
SUPPLEMENTARY INFORMATION: This proposed rule change is designed to
adjust PTO fees in accordance with the applicable provisions of title
35, United States Code; and section 10101 of the Omnibus Budget
Reconciliation Act of 1990 (as amended by section 8001 of Public Law
103-66), all as amended by the Patent and Trademark Office
Authorization Act of 1991 (Public Law 102-204).
Background
Statutory Provisions
Patent fees are authorized by 35 U.S.C. 41 and 35 U.S.C. 376. A
fifty percent reduction in the fees paid under 35 U.S.C. 41(a) and (b)
by independent inventors, small business concerns, and nonprofit
organizations who meet prescribed definitions is required by 35 U.S.C.
41(h).
Subsection 41(f) of title 35, United States Code, provides that
fees established under 35 U.S.C. 41(a) and (b) may be adjusted on
October 1, 1992, and every year thereafter, to reflect fluctuations in
the Consumer Price Index for all urban consumers (CPI-U) over the
previous 12 months.
Section 10101 of the Omnibus Budget Reconciliation Act of 1990
(amended by section 8001 of Public Law 103-66) provides that there
shall be a surcharge on all fees established under 35 U.S.C. 41(a) and
(b) to collect $115 million in fiscal year 1997.
Subsection 41(d) of title 35, United States Code, authorizes the
Commissioner to establish fees for all other processing, services, or
materials related to patents to recover the average cost of providing
these services or materials, except for the fees for recording a
document affecting title, for each photocopy, and for each black and
white copy of a patent.
Section 376 of title 35, United States Code, authorizes the
Commissioner to set fees for patent applications filed under the Patent
Cooperation Treaty (PCT).
Subsection 41(g) of title 35, United States Code, provides that new
fee amounts established by the Commissioner under section 41 may take
effect thirty days after notice in the Federal Register and the
Official Gazette of the Patent and Trademark Office.
Recovery Level Determinations
This proposed rule adjusts patent fees for a planned recovery of
$716,723,000 in fiscal year 1997, as proposed in the Administration's
budget request to the Congress.
The patent statutory fees established by 35 U.S.C. 41(a) and (b)
are proposed to be adjusted on October 1, 1996, to reflect any
fluctuations occurring during the previous 12 months in the Consumer
Price Index for all urban consumers (CPI-U). In calculating these
fluctuations, OMB has determined that the PTO should use CPI-U data as
determined by the Secretary of Labor. However, the Department of Labor
does not make public the CPI-U until approximately 21 days after the
end of the month being calculated. Therefore, the latest CPI-U
information available is for the month of February 1996. In accordance
with previous rulemaking methodology, the PTO uses the Administration's
projected CPI-U for the 12-month period ending September 30, 1996,
which is 3.1 percent. Based on this projection, patent statutory fees
are proposed to be adjusted by 3.1 percent. Before the final fee
schedule is published, the fees may be adjusted slightly based on
updated data available from the Department of Labor.
Certain non-statutory patent processing fees established under 35
U.S.C. 41(d) and PCT processing fees established under 35 U.S.C. 376
are proposed to be adjusted to recover their estimated average costs in
fiscal year 1996. Three patent service fees that are set by statute
will not be adjusted. The three fees that are not being adjusted are
assignment recording fees, printed patent copy fees and photocopy
charge fees.
The proposed fee amounts were rounded by applying standard
arithmetic rules so that the amounts rounded would be convenient to the
user. Fees of $100 or more were rounded to the nearest $10. Fees
between $2 and $99 were rounded to an even number so that any
comparable small entity fee would be a whole number.
[[Page 19225]]
Workload Projections
Determination of workload varies by fee. Principal workload
projection techniques are as follows:
Patent application workloads are projected from statistical
regression models using recent application filing trends. Patent issues
are projected from an in-house patent production model and reflect
examiner production achievements and goals. Patent maintenance fee
workloads utilize patents issued 3.5, 7.5 and 11.5 years prior to
payment and assume payment rates of 79 percent, 55 percent and 32
percent, respectively. Service fee workloads follow linear trends from
prior years' activities.
General Procedures
Any fee amount that is paid on or after the effective date of the
fee increase would be subject to the new fees then in effect. For
purposes of determining the amount of the fee to be paid, the date of
mailing indicated on a proper Certificate of Mailing or Transmission,
where authorized under 37 CFR 1.8, will be considered to be the date of
receipt in the PTO. A Certificate of Mailing or Transmission under
Section 1.8 is not ``proper'' for items which are specifically excluded
from the provisions of Section 1.8. Section 1.8 should be consulted for
those items for which a Certificate of Mailing or Transmission is not
``proper.'' Such items include, inter alia, the filing of national and
international applications for patents and the filing of trademark
applications. However, the provisions of 37 CFR 1.10 relating to filing
papers and fees with an ``Express Mail'' certificate do apply to any
paper or fee (including patent and trademark applications) to be filed
in the PTO. If an application or fee in filed by ``Express Mail'' with
a proper certificate dated on or after the effective date of the rules,
as amended, the amount of the fee to be paid would be the fee
established by the amended rules.
In order to ensure clarity in the implementation of the new fees, a
discussion of specific sections is set forth below.
Discussion of Specific Rules
37 CFR 1.16 National Application Filing Fees
Section 1.16, paragraphs (a), (b), (d), and (f)-(i), if revised as
proposed, would adjust fees established therein to reflect fluctuations
in the CPI. Further, section 1.16, if revised as proposed, would remove
the undesignated text following paragraph (d), and add a new paragraph
(k) including the provisions of such deleted undesignated text. In
addition, Sec. 1.16(k) would also be applicable to any additional fees
required by Secs. 1.16(i) and (j).
37 CFR 1.17 Patent Application Processing Fees
Section 1.17, paragraphs (b)-(g), (m), (r) and (s), if revised as
proposed, would adjust fees established therein to reflect fluctuations
in the CPI.
Section 1.17, paragraphs (j) and (n)-(p), if revised as proposed,
would adjust fees established therein to recover costs.
37 CFR 1.18 Patent Issue Fees
Section 1.18, paragraphs (a)-(c), if revised as proposed, would
adjust fees established therein to reflect fluctuations in the CPI.
37 CFR 1.20 Post-Issuance Fees
Section 1.20, paragraphs (c), (i), and (j), if revised as proposed,
would adjust fees established therein to recover costs.
Section 1.20, paragraphs (e)-(g), if revised as proposed, would
adjust fees established therein to reflect fluctuations in the CPI.
37 CFR 1.21 Miscellaneous Fees and Charges
Section 1.21, paragraph (a)(1), if revised as proposed, would
establish a non-refundable application fee which reflects the costs of
processing an application for the registration examination. Currently,
the PTO evaluates and processes the applications of individuals who do
not qualify for admission or those who withdraw from the examination,
but generally refunds the examination fee to such applicants. Thus,
other fee payers bear the costs of this evaluation and processing. The
proposed amendment would shift the expense of evaluating applications
to all applicants. In order to offset the proposed application fee, the
examination fee is proposed to be slightly decreased.
Section 1.21, paragraphs (a)(3) and (a)(6), if revised as proposed,
would adjust fees established therein to recover costs.
37 CFR 1.445 International Application Filing, Processing, and Search
Fees
Section 1.445, paragraph (a), if revised as proposed, would adjust
the fees authorized by 35 U.S.C. 376 to recover costs and reflect
current business practices.
37 CFR 1.482 International Preliminary Examination Fees
Section 1.482, paragraphs (a)(1)(i), (a)(1)(ii), and (a)(2)(ii), if
revised as proposed, would adjust the fees authorized by 35 U.S.C. 376
to recover costs.
37 CFR 1.492 National State Fees
Section 1.492, paragraphs (a), (b) and (d), if revised as proposed,
would adjust fees established therein to reflect fluctuations in the
CPI.
Other Considerations
This proposed rule change is in conformity with the requirements of
Executive Order 12612, and the Paperwork Reduction Act of 1995, 44
U.S.C. 3501, et seq. This rulemaking contains no information collection
within the meaning of the Paperwork Reduction Act. This proposed rule
has been determined not to be significant for purposes of Executive
Order 12866. The PTO has determined that this proposed rule change has
no Federalism implications affecting the relationship between the
National Government and the States as outlined in Executive Order
12612.
The Assistant General Counsel for Legislation and Regulation of the
Department of Commerce has certified to the Chief Counsel for Advocacy,
Small Business Administration, that the proposed rule change would not
have a significant impact on a substantial number of small entities
(Regulatory Flexibility Act, Pub. L. 96-354). The proposed rule change
increases fees to reflect the change in the CPI as authorized by 35
U.S.C. 41(f). Further, the principal impact of the major patent fees
has already been taken into account in 35 U.S.C. 41(h), which provides
small entities with a 50-percent reduction in the major patent fees.
A comparison of existing and new fee amounts is included as an
Appendix to this notice of proposed rulemaking.
Lists of Subjects in 37 CFR Part 1
Administrative practice and procedure, Inventions and patents,
Reporting and recordkeeping requirements, Small businesses.
For the reasons set forth in the preamble, the PTO is proposing to
amend title 37 of the Code of Federal Regulations, Part 1, as set forth
below.
PART 1--RULES OF PRACTICE IN PATENT CASES
1. The authority citation for 37 CFR Part 1 would continue to read
as follows:
Authority: 35 U.S.C. 6, unless otherwise noted.
2. Section 1.16 is proposed to be amended by revising paragraphs
(a), (b),
[[Page 19226]]
(d), and (f) through (i), and adding a new paragraph (m) to read as
follows:
Sec. 1.16 National application filing fees.
(a) Basic fee for filing each application for an original patent,
except provisional, design or plant applications:
By a small entity (Sec. 1.9(f)).................................$385.00
By other than a small entity....................................$770.00
(b) In addition to the basic filing fee in an original application,
except provisional applications, for filing or later presentation of
each independent claim in excess of 3:
By a small entity (Sec. 1.9(f))..................................$40.00
By other than a small entity.....................................$80.00
* * * * *
(d) In addition to the basic filing fee in an original application,
except provisional applications, if the application contains, or is
amended to contain, multiple dependent claim(s), per application:
By a small entity (Sec. 1.9(f)).................................$130.00
By other than a small entity....................................$260.00
* * * * *
(f) Basic fee for filing each design application:
By a small entity (Sec. 1.9(f)).................................$160.00
By other than a small entity....................................$320.00
(g) Basic fee for filing each plant application, except provisional
applications:
By a small entity (Sec. 1.9(f)).................................$265.00
By other than a small entity....................................$530.00
(h) Basic fee for filing each reissue application:
By a small entity (Sec. 1.9(f)).................................$385.00
By other than a small entity....................................$770.00
(i) In addition to the basic filing fee in a reissue application,
for filing or later presentation of each independent claim which is in
excess of the number of independent claims in the original patent:
By a small entity (Sec. 1.9(f))..................................$40.00
By other than a small entity.....................................$80.00
* * * * *
(m) If the additional fees required by paragraphs (b), (c), (d),
(i) and (j) of this section are not paid on filing or on later
presentation of the claims for which the additional fees are due, they
must be paid or the claims must be canceled by amendment, prior to the
expiration of the time period set for reply by the Office in any notice
of fee deficiency.
3. Section 1.17 is proposed to be amended by revising paragraphs
(b) through (g), (j), (m) through (p), (r), and (s) to read as follows:
Sec. 1.17 Patent application processing fees.
* * * * *
(b) Extension fee for response within second month pursuant to
Sec. 1.136(a):
By a small entity (Sec. 1.9(f)).................................$195.00
By other than a small entity....................................$390.00
(c) Extension fee for response within third month pursuant to
Sec. 1.136(a):
By a small entity (Sec. 1.9(f)).................................$465.00
By other than a small entity....................................$930.00
(d) Extension fee for response within fourth month pursuant to
Sec. 1.136(a):
By a small entity (Sec. 1.9(f)).................................$735.00
By other than a small entity..................................$1,470.00
(e) For filing a notice of appeal from the examiner to the Board of
Patent Appeals and Interferences:
By a small entity (Sec. 1.9(f)).................................$150.00
By other than a small entity....................................$300.00
(f) In addition to the fee for filing a notice of appeal, for
filing a brief in support of an appeal:
By a small entity (Sec. 1.9(f)).................................$150.00
By other than a small entity....................................$300.00
(g) For filing a request for an oral hearing before the Board of
Patent Appeals and Interferences in an appeal under 35 U.S.C. 134:
By a small entity (Sec. 1.9(f)).................................$130.00
By other than a small entity....................................$260.00
* * * * *
(j) For filing a petition to institute a public use proceeding
under
Sec. 1.292....................................................$1,470.00
* * * * *
(m) For filing a petition:
(1) For revival of an unintentionally abandoned application, or
(2) For the unintentionally delayed payment of the fee for issuing
a patent:
By a small entity (Sec. 1.9(f)).................................$645.00
By other than a small entity..................................$1,290.00
(n) For requesting publication of a statutory invention
registration prior to the mailing of the first examiner's action
pursuant to Sec. 1.104--$900.00 reduced by the amount of the
application basic filing fee paid.
(o) For requesting publication of a statutory invention
registration after the mailing of the first examiner's action pursuant
to Sec. 1.104--$1,790.00 reduced by the amount of the application basic
filing fee paid.
(p) For submission of an information disclosure statement under
Sec. 1.97(c)....................................................$230.00
* * * * *
(r) For entry of a submission after final rejection under
Sec. 1.129(a):
By a small entity (Sec. 1.9(f)).................................$385.00
By other than a small entity....................................$770.00
(s) For each additional invention to be examined under
Sec. 1.129(b):
By a small entity (Sec. 1.9(f)).................................$385.00
By other than a small entity....................................$770.00
4. Section 1.18 is proposed to be revised to read as follows:
Sec. 1.18 Patent issue fees.
(a) Issue fee for issuing each original or reissue patent, except a
design or plant patent:
By a small entity (Sec. 1.9(f)).................................$645.00
By other than a small entity..................................$1,290.00
(b) Issue fee for issuing a design patent:
By a small entity (Sec. 1.9(f)).................................$220.00
By other than a small entity....................................$440.00
(c) Issue fee for issuing a plant patent:
By a small entity (Sec. 1.9(f)).................................$325.00
By other than a small entity....................................$650.00
5. Section 1.20 is proposed to be amended by revising paragraphs
(c), (e) through (g), (i)(1), (i)(2), and (j) (1) through (3) to read
as follows:
Sec. 1.20 Post issuance fees.
* * * * *
(c) For filing a request for reexamination
(Sec. 1.510(a))...............................................$2,460.00
* * * * *
(e) For maintaining an original or reissue patent, except a design
or plant patent, based on an application filed on or after December 12,
1980, in force beyond four years; the fee is due by three years and six
months after the original grant:
By a small entity (Sec. 1.9(f)).................................$510.00
By other than a small entity..................................$1,020.00
(f) For maintain an original or reissue patent, except a design or
plant patent, based on an application filed on or after December 12,
1980, in force beyond eight years; the fee is due by seven years and
six months after the original grant:
By a small entity (Sec. 1.9(f))...............................$1,025.00
By other than a small entity..................................$2,050.00
(g) For maintaining an original reissue patent, except a design or
plant patent, based on an application filed on or after December 12,
1980, in force beyond twelve years; the fee is due by eleven years and
six months after the original grant:
By a small entity (Sec. 1.9(f))...............................$1,540.00
By other than a small entity..................................$3,080.00
* * * * *
(i) * * *
(1) Unavoidable.................................................$680.00
(2) Unintentional.............................................$1,600.00
(j) * * *
(1) Application for extension under Sec. 1.740................$1,090.00
(2) Initial application for interim extension under Sec. 1.790
$410.00
(3) Subsequent application for interim
[[Page 19227]]
extension under Sec. 1.790......................................$210.00
6. Section 1.21 is proposed to be amended by revising paragraph
(a)(1), (a)(3), and (a)(6) to read as follows:
Sec. 1.21 Miscellaneous fees and charges.
* * * * *
(a) * * *
(1) For admission to examination for registration to practice:
(i) Application Fee
(non-refundable).................................................$40.00
(ii) Registration examination fee...............................$300.00
* * * * *
(3) For reinstatement to practice................................$40.00
* * * * *
(6) For requesting regrading of an examination under Sec. 10.7(c):
(i) Regarding of A.M. section (PTO Practice and Procedure)......$225.00
(ii) Regarding P.M. section (Claim Drafting)....................$530.00
* * * * *
7. Section 1.445 is proposed to be amended by revising paragraph
(a) to read as follows:
Sec. 1.445 International application filing, processing and search
fees.
(a) The following fees and charges for international applications
are established by the Commissioner under the authority of 35 U.S.C.
376:
(1) A transmittal fee (see 35 U.S.C. 361(d) and PCT Rule 14)....$230.00
(2) A search fee (see 35 U.S.C. 361(d) and PCT Rule 16):
(i) Where a corresponding prior United States National
application filed under 35 U.S.C. 111(a) with the filing fee
under 37 CFR 1.16(a) has been filed.............................$440.00
(ii) For all situations not provided for in (a)(2)(i) of this
section.........................................................$680.00
(3) A supplemental search fee when required, per additional
invention.......................................................$200.00
* * * * *
8. Section 1.482 is proposed to be amended by revising paragraphs
(a)(1)(i), (a)(1)(i), and (a)(2)(ii) to read as follows:
Sec. 1.482 International preliminary examination fees.
(a) * * *
(1) * * *
(i) Where an international search fee as set forth in
Sec. 1.445(a)(2) has been paid on the international application
to the United States Patent and Trademark Office as an
International Searching Authority, a preliminary examination fee
of..............................................................$480.00
(ii) Where the International Searching Authority for the
international application was an authority other than the United
States Patent and Trademark Office, a preliminary examination fee
of..............................................................$730.00
(2) * * *
(i) * * *
(ii) Where the International Searching Authority for the
international application was an authority other than the United
States Patent and Trademark Office..............................$260.00
* * * * *
9. Section 1.492 is proposed to be amended by revising paragraphs
(a), (b), and (d) to read as follows:
Sec. 1.492 National stage fees.
* * * * *
(a) The basic national fee:
(1) Where an international preliminary examination fee as set forth
in Sec. 1.482 has been paid on the international application to the
United States Patent and Trademark Office:
By a small entity (Sec. 1.9(f)).................................$350.00
By other than a small entity....................................$700.00
(2) Where no international preliminary examination fee as set forth
in Sec. 1.482 has been paid to the United States Patent and Trademark
Office, but an international search fee as set forth in
Sec. 1.445(a)(2) has been paid on the international application to the
United States Patent and Trademark Office as an International Searching
Authority:
By a small entity (Sec. 1.9(f)).................................$385.00
By other than a small entity....................................$770.00
(3) Where an international preliminary examination fee as set forth
in Sec. 1.482 has been paid and no international search fee as set
forth in Sec. 1.445(a)(2) has been paid on the international
application to the United States Patent and Trademark Office:
By a small entity (Sec. 1.9(f)).................................$520.00
By other than a small entity..................................$1,040.00
(4) Where an international preliminary examination fee as set forth
in Sec. 1.482 has been paid to the United States Patent and Trademark
Office and the international preliminary examination report states that
the criteria of novelty, inventive step (non-obviousness), and
industrial applicability, as defined in PCT Article 33 (1) to (4) have
been satisfied for all the claims presented in the application entering
the national stage (see Sec. 1.496(b)):
By a small entity (Sec. 1.9(f))..................................$48.00
By other than a small entity.....................................$96.00
(5) Where a search report on the international application has been
prepared by the European Patent Office or the Japanese Patent Office:
By a small entity (Sec. 1.9(f)).................................$455.00
By other than a small entity....................................$910.00
(b) In addition to the basic national fee, for filing or later
presentation of each independent claim in excess of 3:
By a small entity (Sec. 1.9(f))..................................$40.00
By other than a small entity.....................................$80.00
* * * * *
(d) In addition to the basic national fee, if the application
contains, or is amended to contain a multiple dependent claim(s), per
application:
By a small entity (Sec. 1.9(f)).................................$130.00
By other than a small entity....................................$260.00
* * * * *
April 24, 1996.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
Note--The following appendix will not appear in the Code of
Federal Regulations.
Appendix A--Comparison of Existing and Revised Fee Amounts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-Oct
37 CFR Sec. Description 1996 Oct 1996
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.16(a).............................................................................. Basic Filing Fee....................... $750 $770
1.16(a).............................................................................. Basic Filing Fee (Small Entity)........ 375 385
1.16(b).............................................................................. Independent Claims..................... 78 80
1.16(b).............................................................................. Independent Claims (Small Entity)...... 39 40
1.16(c).............................................................................. Claims in Excess of 20................. 22 --
1.16(c).............................................................................. Claims in Excess of 20 (Small Entity).. 11 --
1.16(d).............................................................................. Multiple Dependent Claims.............. 250 260
1.16(d).............................................................................. Multiple Dependent Claims (Small 125 130
Entity).
1.16(e).............................................................................. Surcharge--Late Filing Fee............. 130 --
1.16(e).............................................................................. Surcharge--Late Filing Fee (Small 65 --
Entity).
[[Page 19228]]
1.16(f).............................................................................. Design Filing Fee...................... 310 320
1.16(f).............................................................................. Design Filing Fee (Small Entity)....... 155 160
1.16(g).............................................................................. Plant Filing Fee....................... 510 530
1.16(g).............................................................................. Plant Filing Fee (Small Entity)........ 255 265
1.16(h).............................................................................. Reissue Filing Fee..................... 750 770
1.16(h).............................................................................. Reissue Filing Fee (Small Entity)...... 375 385
1.16(i).............................................................................. Reissue Independent Claims............. 78 80
1.16(i).............................................................................. Reissue Independent Claims (Small 39 40
Entity).
1.16(j).............................................................................. Reissue Claims in Excess of 20......... 22 --
1.16(j).............................................................................. Reissue Claims in Excess of 20 (Small 11 --
Entity).
1.16(k).............................................................................. Provisional Application Filing Fee..... 150 --
1.16(k).............................................................................. Provisional Application Filing Fee 75 --
(Small Entity).
1.16(l).............................................................................. Surcharge--Incomplete Provisional App. 50 --
Filed.
1.16(l).............................................................................. Surcharge--Incomplete Provisional App. 25 --
Filed (Small Entity).
1.17(a).............................................................................. Extension--First Month................. 110 --
1.17(a).............................................................................. Extension--First Month (Small Entity).. 55 --
1.17(b).............................................................................. Extension--Second Month................ 380 390
1.17(b).............................................................................. Extension--Second Month (Small Entity). 190 195
1.17(c).............................................................................. Extension--Third Month................. 900 930
1.17(c).............................................................................. Extension--Third Month (Small Entity).. 450 465
1.17(d).............................................................................. Extension--Fourth Month................ 1,400 1,470
1.17(d).............................................................................. Extension--Fourth Month (Small Entity). 700 735
1.17(e).............................................................................. Notice of Appeal....................... 290 300
1.17(e).............................................................................. Notice of Appeal (Small Entity)........ 145 150
1.17(f).............................................................................. Filing a Brief......................... 290 300
1.17(f).............................................................................. Filing a Brief (Small Entity).......... 145 150
1.17(g).............................................................................. Request for Oral Hearing............... 250 260
1.17(g).............................................................................. Request for Oral Hearing (Small Entity) 125 130
1.17(h).............................................................................. Petition--Not All Inventors............ 130 --
1.17(h).............................................................................. Petition--Correction of Inventorship... 130 --
1.17(h).............................................................................. Petition--Decision on Questions........ 130 --
1.17(h).............................................................................. Petition--Suspend Rules................ 130 --
1.17(h).............................................................................. Petition--Expedited License............ 130 --
1.17(h).............................................................................. Petition--Scope of License............. 130 --
1.17(h).............................................................................. Petition--Retroactive License.......... 130 --
1.17(h).............................................................................. Petition--Refusing Maintenance Fee..... 130 --
1.17(h).............................................................................. Petition--Refusing Maintenance Fee-- 130 --
Expired Patent.
1.17(h).............................................................................. Petition--Interference................. 130 --
1.17(h).............................................................................. Petition--Reconsider Interference...... 130 --
1.17(h).............................................................................. Petition--Late Filing of Interference.. 130 --
1.20(b).............................................................................. Petition--Correction of Inventorship... 130 --
1.17(h).............................................................................. Petition--Refusal to Publish SIR....... 130 --
1.17(i).............................................................................. Petition--For Assignment............... 130 --
1.17(i).............................................................................. Petition--For Application.............. 130 --
1.17(i).............................................................................. Petition--Late Priority Papers......... 130 --
1.17(i).............................................................................. Petition--Suspend Action............... 130 --
1.17(i).............................................................................. Petition--Divisional Reissues to Issue 130 --
Separately.
1.17(i).............................................................................. Petition--For Interference Agreement... 130 --
1.17(i).............................................................................. Petition--Amendment After Issue........ 130 --
1.17(i).............................................................................. Petition--Withdrawal After Issue....... 130 --
1.17(i).............................................................................. Petition--Defer Issue.................. 130 --
1.17(i).............................................................................. Petition--Issue to Assignee............ 130 --
1.17(i).............................................................................. Petition--Accord a Filing Date Under 130 --
Sec. 1.53.
1.17(i).............................................................................. Petition--Accord a Filing Date Under 130 --
Sec. 1.62.
1.17(i).............................................................................. Petition--Make Application Special..... 130 --
1.17(j).............................................................................. Petition--Public Use Proceeding........ 1,430 1,470
1.17(k).............................................................................. Non-English Specification.............. 130 --
1.17(l).............................................................................. Petition--Revive Abandoned Appl........ 110 --
1.17(l).............................................................................. Petition--Revive Abandoned Appl. (Small 55 --
Entity).
1.17(m).............................................................................. Petition--Revive Unintentionally 1,250 1,290
Abandoned Appl.
1.17(m).............................................................................. Petition--Revive Unintent Abandoned 625 645
Appl. (Small Entity).
1.17(n).............................................................................. SIR--Prior to Examiner's Action........ 870 900
1.17(o).............................................................................. SIR--After Examiner's Action........... 1,740 1,790
1.17(p).............................................................................. Submission of an Information Disclosure 220 230
Statement (Sec. 1.97).
1.17(q).............................................................................. Petition--Correction of Inventorship 50 --
(Prov. App.).
1.17(q).............................................................................. Petition--Accord a filing date (Prov. 50 --
App.).
1.17(q).............................................................................. Petition--Entry of submission after 50 --
final rejection (Prov. App.).
[[Page 19229]]
1.17(r).............................................................................. Filing a submission after final 750 770
rejection (1.129(a)).
1.17(r).............................................................................. Filing a submission after final 375 385
rejection (1.129(a)) (Small Entity).
1.17(s).............................................................................. Per add'l invention to be examined 750 770
(1.129(b)).
1.17(s).............................................................................. Per add'l invention to be examined 375 385
(1.129(b)) (Small Entity).
1.18(a).............................................................................. Issue Fee.............................. 1,250 1,290
1.18(a).............................................................................. Issue Fee (Small Entity)............... 625 645
1.18(b).............................................................................. Design Issue Fee....................... 430 440
1.18(b).............................................................................. Design Issue Fee (Small Entity)........ 215 220
1.18(c).............................................................................. Plant Issue Fee........................ 630 650
1.18(c).............................................................................. Plant Issue Fee (Small Entity)......... 315 325
1.19(a)(1)(i)........................................................................ Copy of Patent......................... 3 --
1.19(a)(1)(ii)....................................................................... Patent Copy--Overnight delivery to PTO 6 --
Box or overnight fax.
1.19(a)(1)(iii)...................................................................... Patent Copy by Expedited Mail or Fax-- 25 --
Exp. service.
1.19(a)(2)........................................................................... Plant Patent Copy...................... 12 --
1.19(a)(3)(i)........................................................................ Copy of Utility or SIR in Color........ 24 --
1.19(b)(1)(i)........................................................................ Certified Copy of Patent Application as 15 --
Filed.
1.19(b)(1)(ii)....................................................................... Certified Copy of Patent Application as 30 --
Filed, Expedited.
1.19(b)(2)........................................................................... Cert or Uncert. Copy of Patent-Related 150 --
Filed Wrapper/Contents.
1.19(b)(3)........................................................................... Cert. or Uncert. Copies of Office 25 --
Records, per Document.
1.19(b)(4)........................................................................... For Assignment Records, Abstract of 25 --
Title and Certification.
1.19(c).............................................................................. Library Service........................ 50 --
1.19(d).............................................................................. List of Patents in Subclass............ 3 --
1.19(e).............................................................................. Uncertified Statement-Status of 10 --
Maintenance Fee Payment.
1.19(f).............................................................................. Copy of Non-U.S. Patent Document....... 25 --
1.19(g).............................................................................. Comparing and Certifying Copies, Per 25 --
Document, Per Copy.
1.19(h).............................................................................. Duplicate or Corrected Filing Receipt.. 25 --
1.20(a).............................................................................. Certificate of Correction.............. 100 --
1.20(c).............................................................................. Reexamination.......................... 2,390 2,460
1.20(d).............................................................................. Statutory Disclaimer................... 110 --
1.20(d).............................................................................. Statutory Disclaimer (Small Entity).... 55 --
1.20(e).............................................................................. Maintenance Fee--3.5 Years............. 990 1,020
1.20(e).............................................................................. Maintenance Fee--3.5 Years (Small 495 510
Entity).
1.20(f).............................................................................. Maintenance Fee--7.5 Years............. 1,990 2,050
1.20(f).............................................................................. Maintenance Fee--7.5 Years (Small 995 1,025
Entity.
1.20(g).............................................................................. Maintenance Fee--11.5 Years............ 2,990 3,080
1.20(g).............................................................................. Maintenance Fee--11.5 Years (Small 1,495 1,540
Entity).
1.20(h).............................................................................. Surcharge--Maintenance Fee--6 Months... 130 --
1.20(h).............................................................................. Surcharge--Maintenance Fee--6 Months 65 --
(Small Entity).
1.20(i)(1)........................................................................... Surcharge--Maintenance After 660 680
Expiration--Unavoidable.
1.20(i)(2)........................................................................... Surcharge--Maintenance After 1,550 1,600
Expiration--Unintentional.
1.20(j)(1)........................................................................... Extension of Term of Patent Under 1.740 1,060 1,090
1.20(j)(2)........................................................................... Initial Application for Interim 400 410
Extension Under 1.790.
1.20(j)(3)........................................................................... Subsequent Application for Interim 200 210
Extension Under 1.790.
1.21(a)(1)(i)........................................................................ Application Fee (non-refundable)....... -- 40
1.21(a)(1)(ii)....................................................................... Registration examination fee........... 310 300
1.21(a)(2)........................................................................... Registration to Practice............... 100 --
1.21(a)(3)........................................................................... Reinstatement to Practice.............. 15 40
1.21(a)(4)........................................................................... Certificate of Good Standing........... 10 --
1.21(a)(4)........................................................................... Certificate of Good Standing, Suitable 20 --
Framing.
1.21(a)(5)........................................................................... Review of Decision of Director, OED.... 130 --
1.21(a)(6)(i)........................................................................ Regrading of P.M. section (Claim 130 225
Drafting).
1.21(a(6)(ii)........................................................................ Regrading of A.M. section) PTO Practice 130 530
and Procedure.
1.21(b)(1)........................................................................... Establish Deposit Account.............. 10 --
1.21(b)(2)........................................................................... Service Charge Below Minimum Balance... 25 --
1.21(b)(3)........................................................................... Service Charge Below Minimum Balance... 25 --
1.21(c).............................................................................. Filing a Disclosure Document........... 10 --
1.21(d).............................................................................. Box Rental............................. 50 --
1.21(e).............................................................................. International Type Search Report....... 40 --
1.21(g).............................................................................. Self-Service Copy Charge............... .25 --
1.21(h).............................................................................. Recording Patent Property.............. 40 --
1.21(i).............................................................................. Publication in the OG.................. 25 --
1.21(j).............................................................................. Labor Charges for Services............. 30 --
1.21(k).............................................................................. Unspecified Other Services............. (\1\) --
[[Page 19230]]
1.21(k).............................................................................. Terminal Use APS-CSIR (per hour)....... 50 --
1.21(l).............................................................................. Retaining abandoned application........ 130 --
1.21(m).............................................................................. Processing Returned Checks............. 50 --
1.21(n).............................................................................. Handling Fee--Incomplete Application... 130 --
1.21(o).............................................................................. Terminal Use APS-TEXT.................. 40 --
1.24................................................................................. Coupons for Patent and Trademark Copies 3 --
1.296................................................................................ Handling Fee--Withdrawal SIR........... 130 --
1.445(a)(1).......................................................................... Transmittal Fee........................ 220 230
1.445(a)(2)(i)....................................................................... PCT Search Fee--Prior U.S. Application. 430 440
1.445(a)(2)(ii)...................................................................... PCT Search Fee--No U.S. Application.... 660 680
1.445(a)(3).......................................................................... Supplemental Search.................... 190 200
1.482(a)(1)(i)....................................................................... Preliminary Exam Fee................... 470 480
1.482(a)(1)(ii)...................................................................... Preliminary Exam Fee................... 710 730
1.482(a)(2)(i)....................................................................... Additional Invention................... 140 --
1.482(a)(2)(ii)...................................................................... Additional Invention................... 250 260
1.492(a)(1).......................................................................... Preliminary Examining Authority........ 680 700
1.492(a)(1).......................................................................... Preliminary Examining Authority (Small 340 350
Entity).
1.492(a)(2).......................................................................... Searching Authority.................... 750 770
1.492(a)(2).......................................................................... Searching Authority (Small Entity)..... 375 385
1.492(a)(3).......................................................................... PTO Not ISA nor IPEA................... 1,010 1,040
1.492(a)(3).......................................................................... PTO Not ISA nor IPEA (Small Entity).... 505 520
1.492(a)(4).......................................................................... Claims--IPEA........................... 94 96
1.492(a)(4).......................................................................... Claims--IPEA (Small Entity)............ 47 48
1.492(a)(5).......................................................................... Filing with EPO/JPO Search Report...... 880 910
1.492(a)(5).......................................................................... Filing with EPO/JPO Search Report 440 455
(Small Entity).
1.492(b)............................................................................. Claims--Extra Individual (Over 3)...... 78 80
1.492(b)............................................................................. Claims--Extra Individual (Over 3) 39 40
(Small Entity).
1.492(c)............................................................................. Claims--Extra Total (Over 20).......... 22 --
1.492(c)............................................................................. Claims--Extra Total (Over 20) (Small 11 --
Entity).
1.492(d)............................................................................. Claims--Multiple Dependents............ 250 260
1.492(d)............................................................................. Claims--Multiple Dependents (Small 125 130
Entity).
1.492(e)............................................................................. Surcharge.............................. 130 --
1.492(e)............................................................................. Surcharge (Small Entity)............... 65 --
1.492(f)............................................................................. English Translation--After 20 Months... 130 --
2.6(a)(1)............................................................................ Application for Registration, Per Class 245 --
2.6(a)(2)............................................................................ Amendment to Allege Use, Per Class..... 100 --
2.6(a)(3)............................................................................ Statement of Use, Per Class............ 100 --
2.6(a)(4)............................................................................ Extension for Filing Statement of Use, 100 --
Per Class.
2.6(a)(5)............................................................................ Application for Renewal, Per Class..... 300 --
2.6(a)(6)............................................................................ Surcharge for Late Renewal, Per Class.. 100 --
2.6(a)(7)............................................................................ Publication of Mark Under Sec. 12(c), 100 --
Per Class.
2.6(a)(8)............................................................................ Issuing New Certificate of Registration 100 9--
2.6(a)(9)............................................................................ Certificate of Correction of 100 --
Registrant's Error.
2.6(a)(10)........................................................................... Filing Disclaimer to Registration...... 100 --
2.6(a)(11)........................................................................... Filing Disclaimer to Registration...... 100 --
2.6(a)(12)........................................................................... Filing Affidavit Under Section 8, Per 100 --
Class.
2.6(a)(13)........................................................................... Filing Affidavit Under Section 15, Per 100 --
Class.
2.6(a)(14)........................................................................... Filing Affidavit Under Sections 8 & 15, 200 --
Per Class.
2.6(a)(15)........................................................................... Petitions to the Commissioner.......... 100 --
2.6(a)(16)........................................................................... Petition to Cancel, Per Class.......... 200 --
2.6(a)(17)........................................................................... Notice of Opposition, Per Class........ 200 --
2.6(a)(18)........................................................................... Ex Parte Appeal to the TTAB, Per Class. 100 --
2.6(a)(19)........................................................................... Dividing an Application, Per New 100 --
Application Created.
2.6(b)(1)(i)......................................................................... Copy of Registered Mark................ 3 --
2.6(b)(1)(ii)........................................................................ Copy of Registered Mark, overnight 6 --
delivery to PTO box or fax.
2.6(b)(1)(iii)....................................................................... Copy of Reg. Mark Ordered Via Exp. Mail 25 --
or Fax, Exp. Svc.
2.6(b)(2)(i)......................................................................... Certified Copy of TM Application as 15 --
Filed.
2.6(b)(2)(ii)........................................................................ Certified Copy of TM Application as 30 --
Filed, Expedited.
2.6(b)(3)............................................................................ Cert. or Uncert. Copy of TM-Related 50 --
File Wrapper/Contents.
2.6(b)(4)(i)......................................................................... Cert. Copy of Registered Mark, Title or 10 --
Status.
2.6(b)(4)(ii)........................................................................ Cert. Copy of Registered Mark, Title or 20 --
Status--Expedited.
2.6(b)(5)............................................................................ Certified or Uncertified Copy of TM 25 --
Records.
2.6(b)(6)............................................................................ Recording Trademark Property, Per Mark, 40 --
Per Document.
2.6(b)(6)............................................................................ For Second and Subsequent Marks in Same 25 --
Document.
2.6(b)(7)............................................................................ For Assignment Records, Abstracts of 25 --
Title and Cert.
2.6(b)(8)............................................................................ Terminal Use X-SEARCH.................. 40 --
2.6(b)(9)............................................................................ Self-Service Copy Charge............... 0.25 --
[[Page 19231]]
2.6(b)(10)........................................................................... Labor Charges for Services............. 30 --
2.6(b)(11)........................................................................... Unspecified Other Services............. (\1\) --
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Actual Cost.
--These fees are not affected by this rulemaking.
[FR Doc. 96-10765 Filed 4-30-96; 8:45 am]
BILLING CODE 3510-16-M
Complete official Federal Register PDF
FR Doc. 96-10763 Expedited Procedures for Processing Rail Rate Reasonableness, Exemption and Revocation Proceedings
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19236-19237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10763]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
49 CFR Parts 1100 Through 1149
[STB Ex Parte No. 527]
Expedited Procedures for Processing Rail Rate Reasonableness,
Exemption and Revocation Proceedings
AGENCY: Surface Transportation Board.
ACTION: Advance notice of proposed rulemaking; extension of comment due
date.
-----------------------------------------------------------------------
SUMMARY: The original comment due date in this proceeding of May 6,
1996, is extended to May 20, 1996, at the request of the Association of
American Railroads (AAR), Edison Electric Institute (EEI), National
Grain & Feed Association (NG&FA), National Industrial Transportation
League (NITL), The Society of the Plastics Industry, Inc. (SPI), and
Western Coal Traffic League (WCTL).
DATES: Comments are due on May 20, 1996.
ADDRESSES: Send comments (an original and 10 copies) referring to STB
Ex Parte No. 527 to: Surface Transportation Board, Office of the
Secretary, Case Control Branch, 1201 Constitution Ave., N.W.,
Washington, DC 20423-0001. Parties are encouraged to submit all
pleadings and attachments on a 3.5-inch diskette in WordPerfect 5.1
format.
FOR FURTHER INFORMATION CONTACT: Thomas J. Stilling, (202) 927-7312.
(TDD for the hearing impaired: (202) 927-5721.)
SUPPLEMENTARY INFORMATION: On March 22, 1996, an Advance Notice of
Proposed Rulemaking (ANPR) was served and published in the Federal
Register, at 61 FR 11799, soliciting comments on how existing
regulations could be modified to expedite the handling of rail rate
reasonableness and exemption/revocation proceedings. On April 19, 1996,
AAR, EEI, NG&FA, NITL, SPI, and WCTL jointly requested an extension of
the comment due date until May 20, 1996, so that they can better
respond to the ANPR. Because the parties requesting the extension
represent a significant segment of railroad and shipper interests that
are seeking ``to identify and develop consensus positions on the major
issues,'' the due date for comments is extended to May 20, 1996. Given
our tight statutory deadline, we do not anticipate further extensions.
Decided: April 26, 1996.
[[Page 19237]]
By the Board, Linda J. Morgan, Chairman.
Vernon A. Williams,
Secretary.
[FR Doc. 96-10763 Filed 4-30-96; 8:45 am]
BILLING CODE 4915-00-P
Complete official Federal Register PDF
FR Doc. 96-10732 National Environmental Policy Act; Proposed Revision of Policies and Procedures
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19476-19495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10732]
[[Page 19475]]
_______________________________________________________________________
Part VIII
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 25
National Environmental Policy Act; Proposed Revision of Policies and
Procedures; Proposed Rule
Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 /
Proposed Rules
[[Page 19476]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 25
[Docket No. 96N-0057]
National Environmental Policy Act; Proposed Revision of Policies
and Procedures
Note: This document was originally published at 61 FR 14922,
Wednesday, April 3, 1996. Certain text inadvertently appeared in the
printed version. For the convenience of the reader, the document is
being republished in its entirety.
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing compliance with the National Environmental
Policy Act of 1969 (NEPA) as implemented by the regulations of the
Council on Environmental Quality (CEQ). The primary purpose of this
proposed rule is to increase the efficiency of FDA's implementation of
NEPA and reduce the number of NEPA evaluations by providing for
categorical exclusions for additional classes of actions that do not
individually or cumulatively have a significant effect on the human
environment and for which, therefore, neither an environmental impact
statement (EIS) nor an environmental assessment (EA) is required. FDA
is also proposing to amend its regulations to make its NEPA procedures
more concise and understandable to the public and to reflect current
FDA policy with respect to environmental considerations. This proposed
rule is in response to initiatives announced in the President's
National Performance Reports, ``Reinventing Drug and Medical Device
Regulations,'' April 1995, and ``Reinventing Food Regulations,''
January 1996.
DATES: Submit written comments on the proposed rule by July 2, 1996.
Submit written comments on the information collection requirements by
May 3, 1996.
ADDRESSES: Submit written comments on the proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. Submit written comments on the
information collection requirements to the Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), New
Executive Office Building, 725 17th St. NW., rm. 10235, Washington, DC
20503, Attn.: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT:
For information regarding human drugs: Nancy Sager, Center for Drug
Evaluation and Research (HFD-357), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-6740.
For information regarding biologics: Nancy Roscioli, Center for
Biologics Evaluation and Research (HFM-205), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3031.
For information regarding veterinary medicines: Charles E. Eirkson,
Center for Veterinary Medicine (HFV-150), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855, 301-594-1683.
For information regarding foods: Buzz L. Hoffmann, Center for Food
Safety and Applied Nutrition (HFS-246), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3005.
For information regarding medical devices and radiological health:
Mervin Parker, Center for Devices and Radiological Health (HFZ-402),
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I. Background
NEPA requires all Federal agencies to assess the environmental
impact of their actions and to ensure that the interested and affected
public is informed of environmental analyses. CEQ is responsible for
overseeing Federal efforts to comply with NEPA. Both CEQ and FDA have
issued regulations governing agency obligations and responsibilities
under NEPA. In the Federal Register of March 15, 1973 (38 FR 7001), FDA
issued its first regulations to implement NEPA. FDA amended these
regulations in the Federal Register of April 15, 1977 (42 FR 19986),
based on consideration of revised guidelines for preparing EIS's issued
by CEQ. In 1978, CEQ replaced its guidelines with regulations
implementing the procedural requirements of NEPA (40 CFR parts 1500 to
1508). To comply with CEQ regulations, in the Federal Register of April
26, 1985 (50 FR 16636), FDA revised its NEPA policies and procedures in
part 25 (21 CFR part 25).
The CEQ regulations, which are binding on all Federal executive
agencies, establish formal guidance on the requirements of NEPA.
Agencies must adopt procedures to supplement them. In adopting NEPA-
implementing procedures, Federal agencies are directed by CEQ to reduce
paperwork (40 CFR 1500.4 and 1500.2(b)) and to reduce delay (40 CFR
1500.5) by using several means including the use of categorical
exclusions. CEQ defines categorical exclusions as categories of actions
which do not individually or cumulatively have a significant effect on
the human environment and for which neither an EA nor an EIS is
required (40 CFR 1508.4). The CEQ regulations also state that agencies
shall continue to review their policies and procedures and, in
consultation with CEQ, revise them as necessary to ensure full
compliance with the purpose and provisions of NEPA (40 CFR 1507.3).
II. Overview of the Proposed Rule
Since FDA's NEPA policies and supplemental procedures were
published in 1985, the agency has prepared EA's for many agency-
initiated actions and has reviewed hundreds of EA's for a variety of
industry requests for agency action. Based on FDA's experience
reviewing EA's and on its evaluation and knowledge of other relevant
environmental science, FDA has determined that certain classes of
actions normally do not cause significant environmental effects, and
therefore, should be added to the list of actions that are excluded
from the requirement to prepare an EA or an EIS. Some of these actions
had already been identified by FDA as unlikely to cause significant
environmental effects, as evidenced by the fact that the agency has
been requiring less information to support these actions, i.e., an
abbreviated EA rather than a full EA (see Sec. 25.31a(b)).
Thus, in response to the President's reinventing Government
initiatives announced in the President's National Performance Reports,
``Reinventing Drug and Medical Device Regulations,'' April 1995, and
``Reinventing Food Regulations,'' January 1996, FDA, in consultation
with CEQ, is now proposing to increase the efficiency of FDA's
implementation of NEPA and to substantially reduce the number of NEPA
evaluations by providing for categorical exclusions for additional
classes of actions that do not individually or cumulatively have a
significant impact on the human environment and for which, therefore,
neither an EA nor an EIS is required. This proposal would substantially
reduce the number of EA's required to be submitted by industry and
reviewed
[[Page 19477]]
by FDA and, consequently, reduce the number of findings of no
significant impact (FONSI's) the agency would be required to prepare.
Furthermore, the proposal will not compromise the environment because
the excluded actions have been found not to have a significant effect
on the environment, and the proposed rule would continue to provide for
the preparation of an EA under extraordinary circumstances in which a
categorically excluded action may have a significant environmental
impact. This proposal would enable FDA to focus its resources in the
environmental area on situations likely to have an effect on the
environment.
The agency is also proposing to revise its environmental
regulations to make them more concise and useful to the public and
regulated industry by reorganizing, simplifying, and eliminating
unnecessary and duplicative language. The proposed rule would
reorganize and renumber various sections so that information on certain
topics is grouped together. The agency solicits comments on and
suggestions for further improvement in these regulations.
III. Specific Proposed Changes
A. General Provisions
The proposed rule would eliminate unnecessary language in current
subpart A of part 25 by deleting the reference to the environmental
statutes listed in current Sec. 25.5 Policies, amending Sec. 25.15
Terminology (proposed Sec. 25.5), and making other minor revisions,
including combining Sec. 25.5 Policies and Sec. 25.10 NEPA planning
into proposed Sec. 25.10 Policies and NEPA planning.
In proposed Sec. 25.5 Terminology, FDA is proposing to remove
definitions listed in current Sec. 25.15 that are not used in part 25,
and add new definitions for ``active moiety'' and ``increased use'' of
a drug. ``Increased use'' of a drug will occur if the drug will be
administered at higher dosage levels, for longer duration, or for
different indications than were previously in effect, or if the drug is
a new molecular entity. ``Increased use'' encompasses consideration of
FDA-regulated articles that are disposed of by consumers. ``Active
moiety'' has been previously defined in FDA regulations (21 CFR
314.108(a)).
B. Agency Actions Requiring Environmental Consideration-
Proposed Sec. 25.15 would contain the general procedural
information now found in current Secs. 25.20 and 25.22.
The proposed rule would create new Sec. 25.l6 Public health and
safety emergencies using revised language now contained in current
Sec. 25.40(b).
Actions requiring preparation of an EA (proposed Sec. 25.20) would
remain essentially the same as current Sec. 25.22, except that: (1)
Current Sec. 25.22(a)(13), promulgation and enforcement of FDA
regulations relating to the control of communicable disease and to
interstate conveyance sanitation, has been deleted and is covered by
proposed Sec. 25.20(g); and (2) actions relating to approval of new
drug applications (NDA's) and abbreviated applications, actions on
investigational new drug applications (IND's) (current
Sec. 25.22(a)(14)), issuance of licenses for biologic products (current
Sec. 25.22(a)(16)), and approval of supplements to existing approvals
of FDA-regulated articles (Sec. 25.22(a)(8)) have been combined into
one provision (proposed Sec. 25.20(l)) and revised to reflect current
terminology.
The proposed regulations include new Sec. 25.21 Extraordinary
circumstances, which addresses circumstances under which categories of
actions that would ordinarily be categorically excluded would require
preparation of environmental documents. Proposed Sec. 25.21
incorporates current Sec. 25.23(b) and includes two examples of
circumstances under which an action would require the preparation of
environmental documents because it might have the potential to
significantly affect the environment. The examples of circumstances
that will cause an action not to qualify for categorical exclusion are:
(1) Actions for which data available establish that, at the expected
level of exposure, there is the potential for serious harm to the
environment (proposed Sec. 25.21(a)); and (2) actions that adversely
affect a species or the critical habitat of a species determined under
the Endangered Species Act or the Convention on International Trade in
Endangered Species of Wild Flora and Fauna to be endangered or
threatened, or wild flora or fauna that are entitled to special
protection under some other Federal law (proposed Sec. 25.21(b)). In
addition, the proposed rule references the CEQ regulations at 40 CFR
1508.27, which provide examples of circumstances in which significant
effects may occur. Extraordinary circumstances may be shown by either
data available to the agency or data available to the applicant or
petitioner and may be based on production, use, or disposal from use.
The two examples of extraordinary circumstances in proposed
Sec. 25.21 reflect criteria that appear in some of the categorical
exclusions listed in current Sec. 25.24. The language in the first
example, proposed Sec. 25.21(a), is derived from but differs slightly
from current Sec. 25.24 language relating to toxicity (see, e.g.,
Sec. 25.24(a)(10), (b)(2), and (c)(6)). The extraordinary circumstance
example in proposed Sec. 25.21(a) would revise the language in current
Sec. 25.24, ``the substance may be toxic to organisms in the
environment'' to read ``there may be harm to the environment.'' FDA is
revising this language to reflect that possible adverse environmental
effects other than toxicity should be considered. For example, some
biological agents that may be released may not be toxic to indigenous
organisms, but could have lasting effects on ecological community
dynamics.
FDA considers a substance to be toxic if it is harmful to some
biological mechanism or system. Although FDA recognizes that any
substance may produce damage to biological mechanisms or systems under
specific conditions, for the purposes of these regulations, FDA
considers a substance to be toxic if it is harmful to appropriate test
organisms at the expected level of exposure even though it may be
without effect in humans or other organisms at these concentrations,
and may even be used by humans because of its toxic properties.
As a result of the new language in proposed Sec. 25.21(a), the
words ``toxic'' and ``toxic substance'' are no longer used in the
proposed regulation. Therefore, FDA is proposing to remove the
definition of ``toxic substance'' at current Sec. 25.15(b)(6).
Furthermore, FDA no longer believes that the second part of the current
definition relating to toxicity of a substance is appropriate for the
following reasons: (1) Evaluation of the toxicity of a substance based
only on the concentration at the point of entry or point of highest
concentration ignores factors such as instantaneous dispersion that
typically takes place as a result of processes such as river flow and
wind, and that not all substances bioaccumulate. Consideration of such
dilution processes may be reasonable and scientifically sound in
estimating environmental concentrations for certain purposes; and (2)
the use of a factor of 1/100 of the concentration that causes 50-
percent mortality in a test organism to assess the toxicity of a
substance is not appropriate in all cases. The factors used to assess
toxicity should be directly related to the amount of valid ecotoxicity
data available. Although a factor of 1/100 may be appropriate in some
instances, it may be too much or too little in others. In evaluating
whether extraordinary circumstances exist, FDA will take into
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account any ecotoxicity data relevant to the issue.
The second example of extraordinary circumstances relates to
instances in which the proposed action could adversely affect an
endangered or threatened species, or a species entitled to protection
under some other Federal law. FDA intends to closely examine proposed
actions that involve FDA-regulated articles obtained from wild flora
and fauna and will use the extraordinary circumstances provision to
require at least an EA in any instance in which it appears from an
examination of the proposed action that the action may cause a species
to become endangered or threatened.
In addition, the agency notes that the language in proposed
Sec. 25.21(a) includes the indirect effects as well as direct effects
of agency actions. For example, when the agency takes action to
prohibit or restrict the use of an FDA-regulated product, the agency
may consider whether the increased use of substitutes for the
prohibited or restricted product might, at the expected level of
exposure, result in harm to the environment.
FDA is proposing to remove current Sec. 25.25 (Retroactive
environmental consideration), because any request by FDA to an
applicant to submit additional information to an existing FDA approval
will be made under authority granted to FDA by the Federal Food, Drug,
and Cosmetic Act (the act) or the Public Health Service Act (the PHS
Act).
C. Categorical Exclusions
1. General
The proposed rule would increase the number of categorical
exclusions and reorganize the categorical exclusions into the following
five sections in proposed subpart C of part 25: Section 25.30 General;
Sec. 25.31 Human drugs and biologics; Sec. 25.32 Foods, food additives,
and color additives; Sec. 25.33 Animal drugs, and Sec. 25.34 Devices
and electronic products. The agency is also proposing to delete the
general introductory language from current Sec. 25.24 because it is
unnecessary to include this information in the regulation.-
The agency is proposing to retain most of the general categorical
exclusions listed in current Sec. 25.24(a) (proposed Sec. 25.30) and to
make certain revisions described below:
Current Sec. 25.24(a)(4) categorically excludes destruction or
disposition of any FDA-regulated article condemned after seizure,
following detention or recall at agency request, or the distribution or
use of which has been enjoined. In proposed Sec. 25.30(d), FDA is
proposing to revise the criteria for the categorical exclusion from
``if the method of destruction or disposition of the article, including
packaging material, will not result in the release of a toxic substance
into the environment'' to ``if the waste is disposed of in compliance
with all Federal, State, and local requirements.'' The agency is
proposing this revision to reflect current agency practice and because
the previous criterion is covered under paragraph (a) of proposed
Sec. 25.21 Extraordinary circumstances.
The agency is proposing to revise the categorical exclusion for
current good manufacturing practice (CGMP) regulations
(Sec. 25.24(a)(10), proposed Sec. 25.30(j)) to include regulations
based on the hazard analysis critical control points (HACCP)
principles. The HACCP concept is a systematic approach to the
identification, assessment of risk, and control of the biological,
chemical, and physical food safety hazards associated with a particular
food production process. The HACCP system is based upon the
implementation of a control plan developed by a food producer that
analyzes significant food safety hazards, identifies the points in the
production process where a hazard can be prevented, and determines the
preventive measures that are necessary for proper control.
The agency has recently issued regulations (60 FR 65096, December
18, 1995) that use HACCP principles to ensure the safe processing and
importing of seafood. The agency is also considering developing HACCP
regulations for other regulated food industries (59 FR 39888, August 4,
1994). FDA has found that the environmental considerations based on
HACCP principles are essentially identical to the environmental
considerations of regulations based on CGMP's. Neither type of
regulation is likely to have significant environmental impacts.
Therefore, the agency believes that it is appropriate to incorporate
into the categorical exclusion for CGMP regulations an exclusion of the
HACCP regulations.
FDA also is proposing to add a categorical exclusion (proposed
Sec. 25.30(m)) for actions relating to the disposal of the hazardous
laboratory waste materials generated in FDA laboratories (low-level
radioactive waste and chemical waste). Today, all of this hazardous
waste is disposed of under contract with a hazardous waste management
firm. The contractor is responsible for the collection, handling,
storage, packing, and ultimate disposal of the waste materials at
facilities permitted by the U.S. Environmental Protection Agency (EPA)
and/or facilities licensed by the Nuclear Regulatory Commission (NRC).
In awarding contracts, FDA takes into consideration whether a
prospective contractor has all applicable licenses, permits, and
insurance necessary to perform the work and transport the waste as
required under the contract. The contractor and all disposal facilities
must certify that they are in full compliance with all applicable
Federal, State, and local requirements, before FDA will award the
contract. Further, FDA requires the contractor to present a
comprehensive operational plan. FDA reviews this plan to determine if
the contractor's approach is complete, safe, appropriate, and
responsive to, among other things, FDA's requirements for waste
disposal. Further, the contractor must operate in full compliance with
appropriate regulations issued by EPA (Title 40), the Department of
Transportation (Title 49), the Department of Labor (Title 29), NRC
(Title 10), and with relevant State and local regulations governing the
disposal of hazardous and nonhazardous waste. Therefore, FDA is
proposing in Sec. 25.30(m) to categorically exclude disposal of low-
level radioactive waste materials and chemical waste materials
generated in laboratories serviced by FDA-administered contracts.
2. Human Drugs and Biologics
In the National Performance Report, ``Reinventing Drug and Medical
Device Regulations,'' April 1995, the President announced FDA's
proposal to reduce the number of EA's submitted by industry under NEPA
by increasing the number of categorical exclusions for those actions
relating to drugs and biologics that, as a class, have no individual or
cumulative significant effect on the environment. As described below,
in fulfillment of this commitment, FDA is proposing additional
categorical exclusions for classes of actions on drugs and biologic
products that, based on experience in reviewing these types of actions,
the Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) have concluded do not have
significant effects on the human environment. All of the environmental
reviews of these categories of actions performed under the current
regulations have resulted in FONSI's.
The proposed new categorical exclusions in Sec. 25.31(a) and (b)
apply to actions on an NDA, abbreviated application or a supplement to
such
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applications, or action on an over-the-counter (OTC) monograph. They
are divided into two sections: (1) Proposed Sec. 25.31(a), which
applies if FDA's action does not increase the use and disposal of the
drug; and (2) proposed Sec. 25.31(b), which applies if FDA's action
does increase the use and disposal of the drug. This is similar to the
distinction drawn in the existing regulations between actions that
increase use and actions that do not. Proposed Sec. 25.31(a) and (b)
use the term ``active moiety'' rather than substance, drug product, or
other terminology to clarify the exact focus of the environmental
review.
The categorical exclusion in proposed Sec. 25.31(a) is based on
the categorical exclusions in current Sec. 25.24(c)(1) and (c)(2) and
the fact that, if the action does not increase the use of a drug, there
is no change in the level of the substance in the environment. FDA has
defined ``increased use'' of a drug to include those circumstances
currently listed in Sec. 25.24(c)(1) and (c)(2). Because the
environmental effects, if any, associated with the use and disposal of
the drug were incurred when it was first approved, actions to approve
additional products may be categorically excluded if they do not
increase the use of the drug. Among the actions covered under this
categorical exclusion may be approvals of new dosage forms, prodrugs,
generic drug products, and manufacturing supplements that may change
the method or site of manufacture of a drug but not its use.
Actions under proposed Sec. 25.31(b) that may increase the use or
disposal of a drug product may be categorically excluded if the
concentration of the substance in the environment will be below 1 part
per billion (ppb), the level that FDA has found, based on past
experience, will not significantly affect the aquatic environment. This
reflects a change from current regulations that require an
environmental assessment in any case in which an action may increase
the use of a drug. The basis for this change is described below.
CDER performed a retrospective review of available toxicity
information from EA's that were previously submitted in support of
NDA's and NDA supplements. This information, which includes data from
each review division that are representative of pharmacological drug
classifications, has routinely demonstrated that there are no
significant observed effects on relevant standard test organisms in the
aquatic environment at concentrations below 1 ppb.
Based on the method of entry into the environment from use and
their physical and chemical characteristics (e.g., water solubility),
human drugs would be expected predominantly to enter the aquatic
environment, and the data submitted in EA's reviewed by CDER have
routinely supported this hypothesis. Human drugs and their metabolites
enter the environment from use by excretion from patients. The majority
of hospitals, clinics, and homes in the United States are serviced by a
wastewater treatment facility where compounds are subjected to some
form of aerobic and anaerobic decomposition. Drug and/or metabolites
that are not degraded in the wastewater treatment facility may be
discharged into surface water or removed from the wastewater treatment
plant in sludge.
The data also have routinely shown that in those cases in which an
applicant has provided toxicity results for terrestrial organisms in
addition to acute toxicity results for aquatic organisms, the drugs are
toxic to aquatic organisms at lower levels than they are to terrestrial
organisms, suggesting that the use of aquatic organisms is a
conservative approach.
CDER evaluates the potential for significant environmental effects
by relating the concentrations determined to have toxic effects on
relevant standard test organisms to the level of the substance expected
in the environment. CDER's retrospective review shows that drugs at
concentrations less than 1 ppb in the aquatic environment have no
significant effect on relevant standard test organisms and, therefore,
are unlikely to have a significant effect on the environment. The vast
majority of actions taken by CDER result in the substance being in the
aquatic environment at concentrations less than 1 ppb because the
majority of drugs are produced and used at low levels, and the use of
drugs is not typically localized but rather is spread throughout the
United States.
One of the criteria for determining that a drug is safe for human
use is consideration of its potential to bioaccumulate. The vast
majority of drugs do not have the physical or chemical characteristics
that would allow them to bioaccumulate in tissue because this would
raise safety concerns for use in humans. If a drug does have the
physical or chemical characteristics that would allow it to
bioaccumulate, there has to be a mechanism for the human body to
metabolize the compound to a substance that has lower bioaccumulation
potential so that it is cleared from the body. In the environmental
assessments that CDER reviewed, bioaccumulation has not been an issue.
Thus, FDA has determined that actions that may increase the use or
disposal of a drug should be categorically excluded if the
concentration of the substance in the environment from use will be less
than 1 ppb and no extraordinary circumstances exist. For example, even
under conditions in which an action would increase the use of a drug,
such as an efficacy supplement adding a new indication, the proposed
action may be categorically excluded under this proposal if the
substance in the environment will be below 1 ppb. CDER has provided
guidance on appropriate calculations for estimating environmental
concentrations (Guidance for Industry for the Submission of an
Environmental Assessment in Human Drug Applications and Supplements,
November 1995).
CDER will continue to critically review the environmental toxicity
information submitted for those actions requiring an EA. As additional
data become available to CDER, the agency may propose to modify the 1
ppb environmental concentration cut-off through notice and comment
rulemaking.
Proposed Sec. 25.31(a) and (b) include actions on NDA's. Under the
current regulations (Sec. 25.24(c)(1) and (c)(2)), abbreviated new drug
applications (ANDA's) and supplements may be categorically excluded,
but NDA's for the same type of action may not. Sometimes an applicant
has a choice whether to submit a proposed action as an NDA or ANDA
(e.g., a new dosage form may be submitted as an ANDA with a suitability
petition or as an NDA). Thus, the applicant's choice of submission
would determine whether an EA would need to be submitted. Proposed
Sec. 25.31(a) and (b) would permit FDA to treat NDA's, abbreviated
applications, and supplements alike based on the type of action being
affected by the application.
Current Sec. 25.24(c)(6) categorically excludes actions on OTC
monographs if the product is already marketed for the proposed use. FDA
is proposing to add OTC monographs to proposed Sec. 25.31(a) and (b)
because, by action on an OTC monograph, FDA permits the manufacture and
marketing of OTC drugs that meet the monograph. It should be noted that
actions to switch drugs from prescription to OTC use that are submitted
in an NDA or supplement would also be covered under these provisions.
Proposed Sec. 25.31(a) and (b) would also delete any reference to
``actions on amendments'' to clarify that the agency
[[Page 19480]]
does not take actions on amendments. Amendments are merely changes to a
pending application that are incorporated into the application. The
action the agency takes is on the application as a whole, not on the
amendment.
Proposed Sec. 25.31(a) and (b) applies to drugs regulated by CDER.
FDA is proposing a new categorical exclusion in Sec. 25.31(c) for
substances that occur naturally in the environment, that would apply to
both drugs and biologics. Proposed Sec. 25.31(b) would apply to actions
on an NDA, abbreviated application, application for marketing approval
of a biologic product, a supplement to such applications, or action on
an OTC monograph when the action is not expected to alter significantly
the concentration or distribution of the substance, its metabolites, or
degradation products in the environment. Under the current regulations,
FDA requires an abbreviated EA for a drug that occurs naturally in the
environment. These abbreviated EA's require information about the
production site and about whether the use of the product will
significantly alter the concentration, distribution, and effect of the
natural substance in the environment.
Since the publication of the NEPA regulations in 1985, FDA has
reviewed abbreviated EA's for substances that are naturally occurring.
FDA has found that actions on submissions for these substances will not
affect the environment if the action will not significantly alter the
concentration or distribution of the natural substance in the
environment. Under these circumstances, the agency has prepared
FONSI's. Both CDER and CBER routinely include in safety evaluations
evidence that a product and/or living system used to produce the
product are inactivated following production and prior to release into
the environment, if there is a reasonable possibility that the product
or living system may be harmful to the environment. Therefore, there
are not likely to be any environmental effects. The proposed
regulations would categorically exclude an action for a substance that
occurs naturally in the environment when the action will not alter
significantly the concentration or distribution of the substance in the
environment. FDA has access to information regarding metabolites and
degradation products to aid in determining if the categorical exclusion
request is appropriate.
When an action does alter significantly the concentration or
distribution of a naturally occurring substance, its metabolites, or
degradation products in the environment, e.g., when the use and
disposal will occur in a geographic area where the substance is not
naturally occurring, an EA may be required.
FDA is proposing in Sec. 25.31(d) to expand the categorical
exclusion provision for the withdrawal of approval of an NDA or
abbreviated application. The agency is proposing that all types of
withdrawals of approval, whether requested by industry or initiated by
the agency, be categorically excluded because, based on CDER's
experience, these types of actions will not result in the production or
distribution of any substances and, therefore, will not result in the
introduction of any substance into the environment.
Proposed Sec. 25.31(e) would revise the categorical exclusions for
actions on an IND. Current Sec. 25.24(c)(4) categorically excludes
actions on IND's if the drug shipped under such notice is intended to
be used for clinical studies or research in which waste will be
controlled or the amount of waste expected to enter the environment may
reasonably be expected to be nontoxic. Under proposed Sec. 25.31(e),
FDA would categorically exclude all IND's. In many cases, FDA's actions
on IND's do not significantly increase the use of the drug or the
amount of drug introduced into the environment because the drug is
being tested in few patients or is already being marketed for another
use. Therefore, no changes in environmental effects will occur. In
those cases in which an increase in the use of the drug may occur as a
result of an investigation under an IND, CDER's experience in reviewing
actions on IND's indicates that significant environmental effects will
not occur because the use of such drugs is limited and controlled.
The agency is proposing to delete the language ``if the drug
shipped * * * may reasonably be expected to be nontoxic'' because an
action that results in waste that is expected to be toxic would require
an EA under proposed Sec. 25.21 Extraordinary circumstances.
Proposed Sec. 25.31(g) would add a categorical exclusion for the
testing and release by CBER of lots or batches of a licensed biologic
product. The effects on the environment of licensed biologic products
are evaluated during the safety evaluation and approval of the license
application. Therefore, conducting a separate NEPA review for the
testing and release by CBER of individual lots or batches is
unnecessary.
Proposed Sec. 25.31(i) would permit a categorical exclusion for the
establishment of a comparability determination for a biologic product
subject to licensing. Establishment of a comparability determination
does not result in introduction of a substance into the environment. A
substance will be introduced into the environment only when CBER has
made a comparability determination and subsequently approves a license
application for a specific biologic product. The environmental
considerations will be made in connection with the review of individual
license applications that meet the comparability criteria.
Proposed Sec. 25.31(j) incorporates current Sec. 25.24(c)(10), the
categorical exclusion for promulgation, amendment, or revocation of a
standard for a licensed biologic product, and would eliminate the
current requirement that there be no increased use of the product.
Issuance of additional standards for biologic products (21 CFR parts
620 through 680) does not increase the use of a product. The standards
normally explain how the product is to be manufactured and any
additional requirements for approval and marketing. Therefore, the
increased use criterion is unnecessary.
Proposed Sec. 25.31(k), regarding revocation of a biologic product,
would eliminate the current criteria in Sec. 25.24(c)(9) that the
biological product ``is no longer being marketed'' or that the action
is ``at the request of the license holder.'' The agency is proposing to
delete these criteria as unnecessary because revocation of a license
for a biologic product means that the product can no longer be
marketed. Marketing of the product after license revocation must cease
regardless of whether the revocation was at the request of the license
holder or initiated by the agency. Revocation of a license for a
biologic product under any circumstances will not result in the
introduction of any substance into the environment and, therefore, will
not significantly affect the environment.
The agency is also proposing other minor, nonsubstantive amendments
to delete unnecessary language, improve the accuracy and clarity of the
categorical exclusions, and reflect current terminology.
3. Foods, Food Additives, and Color Additives
In the President's National Performance Report, ``Reinventing Food
Regulations,'' January 1996, the President announced that FDA proposed
to reduce the number of EA's submitted by industry under NEPA by
increasing the number of categorical exclusions for food and color
additives and generally recognized as safe (GRAS)
[[Page 19481]]
substances based on little or no impact on the environment from the use
and disposal of these products. As described below, in fulfillment of
this commitment, FDA is proposing additional categorical exclusions for
actions on foods, food additives, color additives, and GRAS substances
which, based on experience in reviewing these types of actions, the
Center for Food Safety and Applied Nutrition (CFSAN) has concluded will
not significantly affect the human environment.
As was explained previously, FDA is proposing to remove criteria
from certain exclusions in current Sec. 25.24. For actions involving
foods, food additives, color additives, and GRAS substances, the
criteria for the exclusions in current Sec. 25.24(a)(10), (b)(2),
(b)(3), (b)(7), (b)(8), and (b)(9) have been removed. These exclusions
can be located in proposed Secs. 25.30(j), and 25.32(b), (c), (f), (g),
and (h). This change is being made because the provisions in proposed
Sec. 25.21 Extraordinary circumstances could apply to any of the
agency's exclusions, making certain criteria for individual exclusions
unnecessary.
In addition, to reflect current FDA policy, the agency is removing
from part 25 the environmental review requirements for the
establishment of action levels for unavoidable poisonous or deleterious
substances in food or food packaging, and for natural or unavoidable
defects in food that present no health hazard. This change is discussed
below.
For the classes of actions proposed for categorical exclusion in
Sec. 25.32(i), (j), (k), (l), (o), (q), and (r), FDA has traditionally
required certain information to assess the potential environmental
impact of the production of the food additive, color additive, or GRAS
substance. In all cases, FDA has found in its reviews that the
production of these substances did not significantly affect the
environment. The agency has determined that FDA ordinarily will not
consider potential impacts at sites of production of FDA-regulated
products, as discussed in section III.D of this document.
a. Proposed Sec. 25.32(f). Currently, FDA's NEPA procedures in
Sec. 25.24(b)(7) provide for a categorical exclusion for actions
relating to the affirmation of a food substance as GRAS if the
substance is already marketed for the use for which affirmation is
sought. FDA is proposing to expand this categorical exclusion in
proposed Sec. 25.32(f) to include actions to establish and amend
regulations under part 181 (21 CFR part 181) for prior-sanctioned
ingredients that are already marketed in the United States. Actions
involving prior-sanctioned ingredients are similar to certain GRAS
affirmation actions in that the food substance is likely to be already
marketed in the United States for the proposed use at the time the
action is being considered and will continue to be marketed after the
regulation is published. As defined in Sec. 170.3(l) (21 CFR 170.3(l))
and Sec. 181.5(a), a prior sanction shall exist only for a specific use
of a substance for which there was explicit approval by FDA or the U.S.
Department of Agriculture (USDA) before September 6, 1958. Actions to
affirm substances as GRAS or prior-sanctioned for the specific uses for
which they were already marketed in the United States create little or
no change in the introduction of the substance into the environment.
Therefore, such actions have no significant effect on the environment.
b. Proposed Sec. 25.32(i). FDA is proposing to amend its NEPA
procedures to categorically exclude from the requirement to prepare an
EA actions to approve a food additive petition or grant a request for
exemption from regulation as a food additive under Sec. 170.39 (21 CFR
170.39) (threshold of regulation) when a food additive is a functional
component of finished food-packaging materials present at not greater
than 5 percent-by-weight. FDA based this proposed exclusion on its
review of 95 petitions for food additives in this class, all of which
resulted in FONSI's, and on the evaluation of the potential for future
petitions in this class to have significant environmental effects. FDA
has had limited experience in considering the environmental impact of
threshold of regulation submissions because the regulations
establishing a threshold of regulation policy were recently issued (60
FR 36582, July 17, 1995). However, because the information currently
required for such submissions is identical to the information required
for the food-packaging class of indirect food additives discussed in
this section, the agency believes that its experience with the 95 food
additive petitions is relevant to these threshold of regulation
submissions and that these submissions also warrant a categorical
exclusion.
The agency's evaluation of functional components of food-packaging
materials present at not greater than 5 percent-by-weight has
traditionally included consideration of potential impacts relating to
the disposal of food-packaging materials containing the additive and
the use of natural resources and energy.
To determine the potential for significant introductions of
substances into the environment at the site of disposal of food-
packaging materials, i.e., municipal solid waste landfill or combustion
sites, the agency currently requires an estimate of the maximum yearly
market volume for the proposed use of the food additive and the percent
of that amount that will become a component of the finished food-
packaging material. To determine the potential for significant
introductions at landfill sites, FDA estimated the concentration of the
additive that could be present in landfill leachate for each of the 95
petitions it reviewed for additives used as functional components of
food-packaging materials. FDA found that in virtually all cases, the
concentration of the additives in landfill leachate was less than 50
ppb. The concentration of the additives in surface or ground water
receiving landfill leachate was expected to be substantially less,
taking into consideration the mobility and degradation of the additives
in landfills and their dilution in receiving waters.
Consequently, FDA determined in all cases that these extremely low
levels would not have significant environmental impacts at landfill
sites. The agency believes that approvals of future petitions in this
class are even less likely to result in significant introductions of
substances at landfill sites because EPA published new landfill
regulations in the Federal Register of October 9, 1991 (56 FR 50978),
that require new and expanded landfills to have leachate collection
systems and liners to prevent leachate from entering surface or
groundwater. Although operators of existing landfills are not required
to retrofit liner systems, they are required to monitor groundwater
adjacent to existing landfills and to take corrective action as
appropriate.
The agency's evaluation of petitions for additives used as
functional components of food-packaging materials has also shown that
there is little potential for significant introductions from the
combustion of packaging materials containing the additives. These types
of additives are used at low levels in the packaging materials,
5 percent by weight, and, therefore, the additional amounts
of combustion products emitted were found to be insignificant compared
to the levels already being generated during municipal solid waste
combustion. Because FDA's experience shows that the use levels for
additives used as functional components of food-packaging materials are
low, the agency believes that future approvals will also result in
insignificant introductions into
[[Page 19482]]
the environment at municipal solid waste combustor sites.
Under current part 25, FDA requires no documentation to assess
potential impact on energy and resource use if the proposed additive is
intended for the same use as another additive already in use and will
not materially change the potential uses of the packaging materials to
which it is added. The agency has required sponsors to provide
information in an abbreviated EA showing that these criteria are met.
Based on FDA's experience in reviewing petitions for functional
components of food-packaging materials, the agency has found that
petitioners generally were able to demonstrate that a proposed additive
would compete with and replace other, already regulated additives and
that approval would not change the uses of the packaging materials to
which they were added. In cases where a proposed additive did not
compete with and replace an already regulated additive, the agency was
still able to conclude that there would not be a significant impact on
energy and natural resource use largely because use of the additive in
food-contact articles represented a very small fraction of total usage.
Thus, based on the low levels of use of these functional components
of food-packaging materials and on FDA's experience reviewing
abbreviated EA's for these functional components, the agency believes
that approvals of future submissions for such additives are highly
unlikely to have significant effects on the environment. Therefore,
under proposed Sec. 25.32(i) a requestor need not ordinarily submit an
EA.
c. Proposed Sec. 25.32(j). FDA is proposing to categorically
exclude actions to approve a food additive and to grant a request for
exemption from regulation as a food additive under Sec. 170.39 when the
additive is a component of food-contact surfaces of permanent or
semipermanent equipment or of other food-contact articles intended for
repeated use (proposed Sec. 25.32(j)). This proposed exclusion is based
on FDA's experience with 43 petitions for additives used as components
of repeat-use food-contact articles, all of which resulted in a FONSI.
FDA has had limited experience in considering the environmental impact
of threshold of regulation submissions for components of repeat-use,
food-contact articles because the regulations establishing a threshold
of regulation policy were recently issued. However, because the
information currently required for such submissions is identical to the
information required for food additive petitions for these types of
indirect food additives used in repeat-use, food-contact articles, the
agency believes that its experience with the 43 food additive petitions
is relevant to these threshold of regulation submissions and that
approval of these submissions warrants a categorical exclusion.
In reviewing the petitions for components of repeat-use, food-
contact articles, the agency's evaluation of environmental impact has
traditionally included consideration of potential impacts relating to
the disposal of the food-contact articles containing the additive. To
determine the potential for significant introductions of substances
into the environment at the sites of disposal of food additives that
are used as components of the food-contact surfaces of permanent or
semipermanent equipment, or of other repeat-use articles, the agency
currently requires an estimate of the maximum yearly market volume for
the proposed use of the additive. In reviewing abbreviated EA's for
these additives, FDA found that these additives ordinarily have limited
potential for causing significant environmental effects as a result of
their use and disposal. The potential for significant introductions of
substances to the environment due to disposal is, in fact, very low
because of the long service life of the food-contact equipment or other
repeat-use articles, of which additives in this class are components,
and the limited market volumes of the additives as estimated by the
petitioners. Because its actions on these petitions and requests will
not significantly affect the environment, FDA will not ordinarily
require the preparation of an EA.
d. Proposed Sec. 25.32(k). FDA is proposing to categorically
exclude actions to approve food additive, color additive, and GRAS
affirmation petitions for substances added directly to food that are
intended to remain in food through ingestion by consumers and that are
not intended to replace macronutrients in food. This proposed exclusion
is based on FDA's experience reviewing 21 petitions in this class, all
of which resulted in a FONSI. Examples of the types of additives and
GRAS substances that belong to this class are the color additives added
to foods listed in 21 CFR parts 73 and 74, most of the direct food
additives listed in part 172 (21 CFR part 172), and certain GRAS
substances listed in part 184 (21 CFR part 184). Examples of substances
that are not included in the class for which this categorical exclusion
is being proposed are the substances intended to replace macronutrients
in food (such as sweetening agents intended to replace sugar, e.g., see
Secs. 172.800 and 172.804, and fat substitutes, e.g., Sec. 184.1498).
The agency's evaluation of the environmental effects of substances
added directly to food has included consideration of the potential for
impacts from the disposal of human waste products containing the
petitioned substance and/or its products of digestion and metabolism,
and from the use of natural resources and energy.
The substances added directly to food considered here will be
ingested by consumers as components of food containing these
substances. After ingestion, these substances are either digested and/
or metabolized to other substances or excreted largely intact. In all
cases, the agency's review of past actions on substances added directly
to food resulted in decisions to issue FONSI's. To address the
potential for environmental impacts from disposal of this class of
substances, the agency's FONSI's relied on one or more of the following
scenarios: (1) The agency's approval of the petition resulted in very
low levels (in the low ppb range or lower) of the substances in either
effluents and/or sewage sludge from publicly owned wastewater treatment
plants and these levels were determined not to be toxic to organisms in
the environment; (2) the petitioned substance was digested and/or
metabolized by humans such that only products of digestion and
metabolism were expected to be excreted and these products were the
same as (or very similar to) the products of digestion and metabolism
resulting from human food; such products should have no potential for
significant environmental effects because wastewater treatment
facilities are already designed to handle them; or (3) the petitioned
substance was excreted largely intact but was rapidly degraded into
nontoxic products either in wastewater treatment plants or in the
environment.
FDA's experience shows that substances added directly to food and
intended to remain with food through ingestion that are the subject of
new petitions will have use and disposal patterns similar to those
described above and will not be toxic to organisms in the environment
at the expected levels of exposure. Thus, use and disposal of such
substances are not expected to result in significant environmental
effects.
The agency has also found, as a result of its review of petitions
for substances in the class being considered here, that in no case was
there potential for significant impacts on energy and natural
resources. These findings relied on one or more of the following
[[Page 19483]]
scenarios: (1) The substances were expected to compete with and replace
other already regulated substances with no significant change in the
overall use of natural resources or energy, (2) the substances are also
used in nonfood contact situations and the food-contact usage
represented a small increase in the overall production and usage of the
substance such that the small increase in the uses of natural resources
and energy was not significant, or (3) the predicted market volumes for
the petitioned substances were very small so that the use of natural
resources and energy for the petitioned substances was very limited. In
no case did the agency find that there would be any effects on
threatened or endangered species. Because the use and disposal of
substances added directly to foods and intended to remain with foods
through ingestion has no significant effect on the environment and has
very limited potential for significant effects on energy and natural
resources, EA's for these substances will not ordinarily be required.
e. Proposed Sec. 25.32(l). FDA is proposing to categorically
exclude actions to approve color additives used in contact lenses,
sutures, polymethylmethacrylate filaments used in supporting haptics
for intraocular lenses, bone cement, and in other FDA-regulated
products that involve similar low levels of use. The agency reviewed
EA's for 20 color additive petitions for these types of uses and found
that all proposed uses involve small amounts of color additives.
Because of the nature of these uses, the highest annual market volume
encountered for any of these color additives was 12 kilograms (kg),
while most of the petitioned uses involved considerably less than 5 kg.
Consequently, the environmental introduction levels of the color
additives from manufacture, use, and disposal would be exceedingly
small. FDA's experience shows that petitions for color additives in
these types of applications will have very low market volumes such that
only extremely low levels of substances will be introduced into the
environment and will not cause significant environmental effects.
Therefore, FDA is proposing to categorically exclude actions on such
petitions from the requirement to prepare an EA.
f. Proposed Sec. 25.32(m). FDA is proposing to categorically
exclude actions to prohibit or otherwise restrict or reduce the use of
a substance in food, food packaging, or cosmetics, e.g., the withdrawal
of approval for the use of a food or color additive, removal of the use
of a substance from a GRAS list (21 CFR parts 182, 184, and 186), or
prohibition of the use of a prior-sanctioned substance (defined under
Secs. 170.3(l) and 181.5(a)). The agency has prepared EA's for 12
actions to withdraw approval for the use of a food or color additive or
to prohibit the use of a substance in food. The agency has prepared
only one EIS for the withdrawal of approval of a food additive. In
1978, the agency prepared an EIS for its action to prohibit the use of
certain chlorofluorocarbons in food, food additive, drug, animal food,
animal drug, cosmetic, and medical device products as propellants in
self-pressurized containers (43 FR 11301, March 17, 1978). The
specified chlorofluorocarbons were prohibited because their continued
use was predicted to result in the depletion of the stratospheric ozone
layer. FDA prepared the EIS as part of an interagency effort to address
this problem. CEQ determined that an EIS was necessary for this
particular action because of the controversy surrounding the scientific
issues associated with the potential effects of these chemicals on
stratospheric ozone. The agency considers its action on
chlorofluorocarbons to be an exception. It is the only action of this
type that involved potentially significant effects on the environment.
The effect of withdrawing approval or prohibiting the use of a
substance is to reduce or eliminate environmental exposure to that
substance. Thus, no potential exists for direct adverse environmental
effects from the agency's prohibition of the use of a substance. It may
sometimes be necessary, however, to consider the potential indirect
environmental effects that would result from increased use of
substitutes for the prohibited substance. Since the agency began
considering the environmental impact of its actions under NEPA, it has
not found that significant adverse environmental effects would result
from the increased use of a substitute for a food or color additive or
other food substance that was being restricted. In the agency's
evaluation of past actions in this class, the agency has found that
there are frequently a number of substitutes for the prohibited
substance. Thus, the increase in production, use, or disposal of
substitutes is spread among a number of substances. Further,
environmental exposure to any one substitute is minimal. In some cases,
the agency has found that substitutes have been previously subjected to
environmental review under NEPA by the agency, and that this review
encompassed the use of the substitute as a replacement for the
prohibited substance and resulted in an EA and FONSI being prepared.
Any new food or color additive that may be developed to replace a
prohibited one would undergo environmental review during the premarket
approval process.
g. Proposed Sec. 25.32(n). FDA is proposing to categorically
exclude actions to issue, amend, or revoke regulations pertaining to
infant formulas. FDA is proposing to exclude actions on infant formulas
because they have little or no potential for adverse environmental
effects. The preparation, distribution, and directions for use of
infant formulas are carefully controlled by regulations in 21 CFR parts
106 and 107 and, along with other foods, by the CGMP regulations in 21
CFR part 110. In addition, the nature of this product, a food designed
for infants, means that the product itself is very unlikely to cause
adverse environmental impacts. Infant formulas are expected to be used
and disposed of in a manner similar to other human food, but infant
formulas form only a small fraction of the total human food supply
since they are used only in the first year or 2 of human life.
Therefore, it is unlikely that future actions on infant formulas will
have potential for significant environmental effects, and thus, FDA is
proposing to exclude them from the requirement to prepare an EA.
h. Proposed Sec. 25.32(o). FDA is proposing to exclude actions to
approve a food additive petition when an additive is the intended
expression product(s) present in food derived from new plant varieties.
The proposed exclusion is based on our determination that the USDA
Animal and Plant Health Inspection Service (APHIS) has lead
responsibility, under the Federal Plant Pest Act (7 U.S.C. 150aa et
seq.), to prevent the movement and dissemination in the United States
of plant pests. Under that authority, USDA APHIS addresses the
potential of new plant varieties to pose a plant pest risk in
accordance with the requirements mandated under NEPA. USDA considers
the potential for risk in a very broad context, so that not only is
direct disease or damage to plants and plant materials considered as a
component of plant pest risk, but indirect effects on beneficial or
other organisms in the agronomic context are also addressed. Before
issuing a determination of nonregulated status for an organism that has
been subject to USDA oversight because it was considered to present a
potential risk of being a plant pest, USDA conducts an environmental
analysis in compliance with its NEPA requirements that addresses plant
pest
[[Page 19484]]
risk characteristics, disease and pest susceptibilities, expression of
any introduced gene products and effects thereof, new enzymes, or
changes to plant metabolism, weediness of the plant, impact on the
weediness of any other plant with which it can interbreed, agricultural
or cultivation practices, effects of the plant on nontarget organisms,
indirect plant pest effects on other agricultural products, transfer of
genetic information to organisms with which it cannot interbreed, and
any other information believed to be relevant to a determination. The
issues considered by FDA are the same or a subset of the issues that
USDA addresses as part of its NEPA review. Therefore, a NEPA review by
FDA would be redundant.
i. Proposed Sec. 25.32(p). FDA is proposing to categorically
exclude actions under part 101 (21 CFR part 101) to issue, amend, or
revoke a regulation in response to a reference amount petition
(Sec. 101.12(h)), a nutrient content claim petition (Sec. 101.69), a
health claim petition (Sec. 101.70), or a petition pertaining to the
label declaration of ingredients (Sec. 101.103). The agency has
regulations pertaining to various aspects of food labeling in part 101.
These regulations include provisions that enable interested persons to
petition the agency to issue regulations on several subjects related to
labeling, listed above. These petitions must include, under current
regulations, either a claim for categorical exclusion under current
Sec. 25.24 or an EA under current Sec. 25.31.
Current Sec. 25.24(a)(11) contains an exclusion for the
establishment or repeal by regulation of labeling requirements for
marketing articles, ``if there will be no increase in the existing
levels of use or change in the intended uses of the product or its
substitutes.'' The criteria are intended to ensure that the excluded
labeling actions will not cause significant environmental effects. This
exclusion can be used with petitions of the type listed above, if
petitioners demonstrate that the criteria are met. For those actions
that would not qualify for exclusion under current Sec. 25.24(a)(11)
because there will be an increase in the use of the product, FDA now
believes that this increased use will not have significant
environmental effects. Thus, the agency has determined that a specific
unqualified categorical exclusion for petitions related to food
labeling is appropriate.
When changes in the labeling on food products are allowed, there is
a potential for changes in the levels of use, and in the intended uses,
of such products or their substitutes. In fact, nutrient content claims
and health claims are generally intended to increase the use of the
labeled product. However, the changes that will result from FDA's
actions on the types of petitions listed above will be modifications of
the purchasing and consumption habits of consumers. A food labeled in
the newly allowed manner will be purchased and consumed instead of
another food that, for a variety of reasons, will not be labeled in
this new manner. The net result will be the substitution of one food
for a similar food. Thus, no significant adverse effects on the
environment will result. Therefore, the agency is proposing that its
future actions on petitions for the issuance, amendment, or revocation
of regulations on reference amounts customarily consumed per eating
occasion (Sec. 101.12(h)), on nutrient content claims (Sec. 101.69), on
health claims (Sec. 101.70), and on the label declaration of
ingredients (Sec. 101.103) be categorically excluded from the
preparation of an environmental assessment.
j. Proposed Sec. 25.32(q). FDA is proposing in Sec. 25.32(q) to
categorically exclude from the requirement to submit an EA actions to
approve food additive petitions for substances registered by EPA under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7
U.S.C. 136 et seq.) for the same use requested in the petition. FDA has
had limited experience in considering the environmental impact of
threshold of regulation submissions for substances registered by EPA
under FIFRA because the regulations establishing threshold of
regulation policy were recently issued. However, because the
information currently required for such submissions is identical to the
information required for food additive petitions for these types of
substances, the agency believes that its experience with food additive
petitions is relevant. This proposed exclusion is based on FDA's
experience reviewing 12 petitions in this class, all of which resulted
in a FONSI. All of these petitions were for antimicrobial substances
used either in the processing of food or in food-packaging materials.
FDA's evaluation of the potential environmental effects of
antimicrobial substances has included consideration of potential
impacts at the site of use and disposal of the antimicrobial substance,
and from the use of natural resources and energy. Currently, for the
use sites of antimicrobial substances, petitioners are directed to rely
on information in studies submitted to EPA for registration of the
product under FIFRA, and to describe any potential adverse
environmental effects determined by EPA. Petitioners may submit a brief
description and summary of results of EPA studies in lieu of the
complete test reports. For use sites, FDA has based its environmental
decision on a prediction of exposure levels, using introduction and
fate information, that is compared with relevant toxicological data to
determine the potential for significant environmental effects.
The agency's experience with antimicrobial petitions has been that,
before an antimicrobial product can be used in food-contact situations,
EPA will have already examined the environmental risks and benefits of
registering the product under FIFRA. The parallel between EPA's review
and FDA's environmental review is illustrated by FDA's finding that it
has not had to require environmental testing for antimicrobial products
because such tests were already conducted as part of EPA's review. In
addition, antimicrobial substances that are used and discharged at
point sources within the United States are subject to the requirements
of National Pollution Discharge Elimination System (NPDES) permits
under the Clean Water Act (33 U.S.C. 1251 et seq.). In registering a
product under FIFRA, EPA requires the label to state that: (1) The
product is not to be discharged into lakes, streams, ponds, estuaries,
oceans, or other waters unless in accordance with the requirements of
an NPDES permit and unless the permitting authority has been notified
in writing prior to discharge; and (2) the product is not to be
discharged to sewer systems without previously notifying the local
sewage treatment plant authority. EPA also requires, if necessary, that
labels contain information such as a warning of toxicity to fish and/or
wildlife, as specified in 40 CFR 156.10(h)(2)(ii). Thus, FDA has found
that its assessment of the fate and effects of antimicrobial substances
essentially duplicates the review by EPA under FIFRA and, to some
extent, the review by NPDES permitting authorities under the Clean
Water Act.
Currently, petitioners must address the potential for impact on
the use of natural resources and energy as required in an EA by
specifying the natural resources and energy required to produce,
transport, use, and/or dispose of a given amount of the product that is
the subject of the action. FDA's experience with this area of potential
impacts is that these types of substances almost always compete with
and replace other similar substances so that there is little or no
change in the use of natural resources and energy. Thus, FDA believes
that future food additive petitions for the same use as pesticides
[[Page 19485]]
approved by EPA under FIFRA will have little or no potential for
significant environmental impacts and that FDA's actions on these
petitions warrant exclusion from the requirement to prepare an EA.
k. Removal of action levels. At the time the current environmental
regulations were issued, the agency believed that the establishment of
an action level required environmental review. Thus, the agency
included a paragraph for the establishment of action levels in current
Sec. 25.22(a)(11) and specified an EA format in current Sec. 25.31d.
FDA also provided a categorical exclusion in current Sec. 25.24(b)(6)
for action levels for natural or unavoidable defects in food for humans
or animals if these defects presented no health hazard.
In 1987, in a limited holding, the Court of Appeals for the D.C.
Circuit in Community Nutrition Institute v. Young, 818 F.2d 943 (D.C.
Cir. 1987), found that FDA was treating its action levels as
substantive, legislative rules and, thus, action levels were subject to
the notice-and-comment requirements of the Administrative Procedure Act
(5 U.S.C. 551 et seq.). The court recognized, however, that FDA could
proceed by action levels that are not binding rules. Since the court's
holding, FDA has followed this approach. Under its statutory authority
under 21 U.S.C. 342(a)(1), (a)(2)(A), and 346 to limit the amount of
poisonous or deleterious substances in food, FDA establishes ``action
levels'' to inform food producers of the level of contaminants in food
that may result in regulatory action. Action levels are not intended to
bind the public, or FDA, or to create or confer any rights, privileges,
immunities, or benefits on or for any private person, but are intended
merely for internal FDA guidance for deciding whether to bring an
enforcement action. The establishment of an action level is not agency
action and is not subject to NEPA.
Moreover, under CEQ regulations (40 CFR 1508.18(a)), bringing
judicial, administrative, civil, or criminal enforcement actions is not
major Federal action. Because establishment of action levels is
intended merely for internal guidance for deciding whether to bring an
enforcement action, establishment of an action level is not major
Federal action.
Therefore, FDA is proposing to remove all references to action
levels from part 25. The agency will continue to apply these
regulations to the establishment of tolerances for poisonous or
deleterious substances in food for human or animal consumption or in
packaging materials intended for use with human food and animal feeds.
l. Proposed Sec. 25.32(r). FDA is proposing to categorically
exclude actions to approve a food additive, a color additive, or a GRAS
affirmation petition for a substance that occurs naturally in the
environment, when the action is not expected to alter significantly the
concentration or distribution of the substance, its metabolites, or
degradation products. This proposed exclusion is based on FDA's review
of 19 petitions for substances in this class, all of which resulted in
a finding of no significant impact.
The agency currently requires limited information for substances
that occur naturally in the environment, as specified in the
abbreviated EA format in current Sec. 25.31a(b)(5). This format focuses
on whether the use of the substance can reasonably be expected, on the
basis of all available evidence, to alter significantly the
concentration and distribution of the substance, its metabolites, or
degradation products in the environment and on information about the
environmental effects of substances expected to be emitted into the
environment. From its review of 19 petitions, the agency has found that
the use of naturally occurring substances as food additives, color
additives, or GRAS substances did not alter significantly the
concentration and distribution of the substance, its metabolites or
degradation products in the environment, and therefore, substances
emitted into the environment did not have adverse environmental
effects.
Among the 19 petitions for naturally occurring substances reviewed
by the agency were several petitions for substances intended to replace
macronutrients in food. In Sec. 25.32(k), FDA is not proposing to
exclude from the requirement to prepare an EA petitions for substances
intended to replace macronutrients. However, when a macronutrient
replacement is also a substance that occurs naturally in the
environment, the categorical exclusion proposed here will apply, unless
the agency finds that extraordinary circumstances exist, as delineated
in proposed Sec. 25.21.
4. Veterinary Drugs and Feed Additives
The National Performance Report, ``Reinventing Food Regulations,''
January 1996, announced FDA's proposal to reduce the number of EA's
submitted by industry under NEPA by increasing the number of
categorical exclusions for actions relating to animal drugs, animal
feeds, and food and color additives, which as a class have no
individual or cumulative significant effects on the environment. As
described below, in fulfillment of this commitment, FDA is proposing
additional categorical exclusions for actions on animal drugs and feed
additives that, based upon its experience in reviewing these types of
actions, the Center for Veterinary Medicine (CVM) has concluded will
not significantly affect the human environment.
Under proposed Sec. 25.33(a), actions relating to new animal drug
applications (NADA's), abbreviated applications, and suppleme
FR Doc. 96-10732 National Environmental Policy Act; Proposed Revision of Policies and Procedures
nts to
such applications that do not increase the use and disposal of the
substances are categorically excluded.
Proposed Sec. 25.33(a) includes the categorical exclusions listed
in current Sec. 25.24(d)(1) and (d)(2), and broadens the categorical
exclusion to allow FDA to categorically exclude other actions that do
not result in increased use of a drug and, consequently, do not result
in an increase in the expected level of environmental exposure. For
example, the approval of a supplement for a new manufacturing site is
not specifically listed but may be categorically excluded if it is not
expected to result in increased use of the substance for which the
supplement was submitted. Proposed Sec. 25.33(a)(7) for animal drugs
used in feeds is the same as current Sec. 25.24(d)(2) but has been
revised for clarity because FDA approves animal drugs for use in animal
feeds.
The categorical exclusions in proposed Sec. 25.33(a) include
actions relating to abbreviated new animal drug applications (ANADA's)
in recognition of the creation of ANADA's under the 1988 Generic Animal
Drug and Patent Term Restoration Act (GADPTRA) (21 U.S.C. 301 note). An
ANADA is merely an abbreviated form of an NADA and seeks to effectuate
the same action, approval of an animal drug. Therefore, the nature of
environmental considerations is similar. For animal drugs not otherwise
excluded in Sec. 25.33(a), the agency is reserving Sec. 25.33(b) to
provide for a categorical exclusion analogous to that contained in
proposed Sec. 25.31(b) for human drugs. The categorical exclusion would
be for actions that increase the use of an animal drug in the instance
that the agency determines a level at or below which the concentration
of the substance in the environment does not significantly affect the
environment.
FDA recognizes that proposed Sec. 25.31(b) for human drugs allows
for a categorical exclusion for increased uses of human drugs if the
concentration of the substance in the aquatic
[[Page 19486]]
environment will be at or below 1 ppb. At this time, FDA is not
adopting a specific environmental concentration from use of animal
drugs because the agency is still conducting a retrospective review of
environmental assessments for these products and a review of relevant
environmental science. The Animal Health Institute and FDA/CVM held an
Environmental Risk Assessment Workshop on February 20 and 21, 1996, to
establish a comprehensive ecological risk assessment process for the
evaluation of animal health products. Following this opportunity for
public debate, and for drugs not otherwise excluded, FDA will adopt a
risk assessment paradigm for determining environmental introductions
for animal drugs and an environmental concentration at or below which
no meaningful environmental effects are expected to occur.
Proposed Sec. 25.33(c) would categorically exclude any action on
an NADA, abbreviated application, or a supplement to such actions for
substances that occur naturally in the environment, when the action is
not expected to alter significantly the concentration or distribution
of the substance, its metabolites, or degradation products in the
environment. Currently, FDA's regulations require an abbreviated EA for
an animal drug substance that occurs naturally in the environment.
These abbreviated EA's require information about the production site
and about whether the use of the product will significantly alter the
concentration, distribution, and effect of the natural substance in the
environment.
Since the publication of the NEPA regulations in 1985, FDA has
reviewed abbreviated EA's for substances that are naturally occurring.
FDA has found that actions on submissions for these substances will not
affect the environment if the action will not significantly alter the
concentration or distribution of the natural substance in the
environment. Under these circumstances, the agency has prepared
FONSI's.
Therefore, the proposed regulations would categorically exclude
actions on an NADA, abbreviated application, or a supplement to such
applications for substances that occur naturally in the environment
when the action is not expected to alter significantly the
concentration or distribution of the substance, its metabolites, or
degradation products in the environment. FDA has access to information
regarding metabolites and degradation products to aid in determining if
the categorical exclusion request is appropriate. Neither an EA nor an
EIS would be required for such actions. When an action does alter
significantly the concentration or distribution of the products, its
metabolites, or degradation products in the environment, e.g., when the
use and disposal will occur in a geographic area where the substance is
not naturally occurring, an environmental assessment may be required.
Proposed Sec. 25.33(d) includes categorical exclusions for actions
relating to approval of applications for animal drugs intended for use
in nonfood animals, for local or general anesthesia, for ophthalmic or
topical applications, for the treatment of a disease occurring in minor
species animals, as defined in Sec. 514.1(d)(1)(i) (21 CFR
514.1(d)(1)(i)), and for use under prescription or veterinarian's
order. Under current Sec. 25.31a(b)(4), FDA requires abbreviated EA's
to be submitted as part of any request for such approvals. These
abbreviated EA's require environmental information for production
sites. Since the publication of the NEPA regulation in 1985, CVM has
reviewed many abbreviated EA's for these types of products. In every
instance, the agency has prepared a FONSI because the manufacturing was
determined to be in compliance and would remain in compliance with the
Federal, State, and local environmental requirements that apply to the
site of manufacturing, and the market volume for such products was so
low that FDA found, based on its experience, the drugs would not
significantly affect the environment. Furthermore, as the agency
explains in section III.D. of this document, the agency has determined
that ordinarily FDA will not consider potential impacts at the site of
production.
The categorical exclusion for local and general anesthetic products
applies only to those products that are administered individually. Some
anesthetic products may be intended to be administered to many animals
or in significant quantities. In these instances, potential
environmental effects exist that require environmental analysis. The
exclusion for ophthalmic and topical products is limited to those
products intended for nonsystemic use. Products used systemically could
result in greater environmental introductions that could potentially
affect the environment and, therefore, require further environmental
analysis. Furthermore, FDA is clarifying that the categorical exclusion
for drugs for minor species applies only to those animal drugs that
have been previously approved for use in another or the same species
when similar animal management practices are used. When management
practices are different, environmental introductions and impacts may
also be different and require environmental analyses. Minor species
include wildlife and endangered species (Sec. 514.1(d)(1)(ii)).
The categorical exclusion for animal drugs used under prescription
or veterinarian's order applies only to animal drugs for therapeutic
uses as defined in section 201(g)(1)(B) of the act (21 U.S.C.
321(g)(1)(B)). Based on its experience in reviewing EA's for these
products, FDA has found that prescription products are generally
administered individually to a limited number of animals for a limited
amount of time. Therefore, there are no significant environmental
effects. However, FDA may require an EA if the agency determines that
there are extraordinary circumstances associated with the use of such a
product.
Current Sec. 25.24(d)(4) categorically excludes actions on an
investigational new animal drug application (INAD) if the drug to be
shipped under such notice is intended to be used for clinical studies
or research in which wastes will be controlled or the amount of wastes
expected to enter the environment may reasonably be expected to be
nontoxic. Under proposed Sec. 25.33(e), FDA would categorically exclude
all actions on INAD's. In many cases, FDA's actions on INAD's do not
significantly increase the use of the drug and, thus, the amount of
drug introduced into the environment. Therefore, no changes in
environmental effects will occur. In those cases where an increase in
use of a drug may occur as a result of an investigation under an INAD,
FDA's experience from reviewing many actions on INAD's shows that
significant environmental effects will not occur because the use of
such drugs is limited and controlled.
Proposed Sec. 25.33(f) would categorically exclude actions on
applications submitted under section 512(m) of the act (21 U.S.C.
360b(m)). FDA is proposing to exclude actions on such applications
because they permit feed manufacturers to manufacture animal feed
bearing or containing new animal drugs previously approved for use in
feeds. The potential for environmental effects to occur is considered
at the time the new animal drug is approved for use in feed. Therefore,
there is no need to require an additional EA each time the agency
considers approval of an application submitted under section 512(m) of
the act.
[[Page 19487]]
Current Sec. 25.24(d)(3) categorically excludes withdrawals of
approval of NADA's when the drug is no longer marketed or at the
request of the application holder. Under proposed Sec. 25.33(g), FDA
would categorically exclude withdrawals of approval of ANADA's, as well
as withdrawals of approval of NADA's, without conditions. FDA has
determined that withdrawal of an NADA or ANADA approval does not
significantly affect the environment because any change in introduction
of the drug will generally be a decrease.
Under proposed Sec. 25.33(h), FDA would categorically exclude
actions to withdraw the approval for uses of food additives in animal
feeds or to remove substances for use in animal feeds from the GRAS
list or to remove substances from the GRAS list (parts 182, 184, or
186). Withdrawal or removal of a food additive substance that reduces
or eliminates animal feed use will not significantly affect the
environment because any change in introduction of the substance to the
environment will generally be a decrease.
In those cases where the withdrawal of the NADA, ANADA, or FAP, or
GRAS substance has resulted in the use of a substitute product, the
agency has found in all instances that the increased use of the
substitutes will not significantly affect the environment.
FDA is proposing to eliminate the categorical exclusions under
current Sec. 25.24(d)(5) and (d)(6) because FDA does not do testing and
certification of batches of antibiotics for animal use, and FDA does
not use monographs for animal drugs. FDA is proposing to eliminate
current Sec. 25.24(d)(7). This action takes place under an INAD, and
its effect is to set the standard for approving ANADA's. FDA will
determine whether it needs to consider environmental effects when it
approves individual ANADA's.
5. Devices and Electronic Products
The agency is proposing to redesignate current Sec. 25.24(e) as
proposed Sec. 25.34 and to remove criteria in Sec. 25.24(e)(4) and
(e)(7), now incorporated in proposed Sec. 25.21 Extraordinary
circumstances.
D. Subpart D--Preparation of Environmental Documents
The proposed rule would reorganize current subpart C of part 25 to
improve the usefulness and readability of the current regulations.
Proposed Sec. 25.40(b) would eliminate the EA and abbreviated EA
formats and delete any reference to formats. After consultation with
CEQ, the agency has decided to remove the standard formats from part
25, and to provide appropriate formats in guidance documents. Guidance
documents, which do not bind the agency or the public, are more easily
revised. Use of such documents will give FDA greater flexibility to
tailor environmental documents to reflect state-of-the-art developments
in environmental analysis and to assist companies in focusing on
important environmental issues. Information/guidance concerning the
nature and scope of information that an applicant or petitioner should
submit in an EA may be obtained from the center responsible for the
action subject to environmental evaluation (proposed Sec. 25.40(c)).
In the Federal Register of January 11, 1996, FDA announced the
availability of a guidance document entitled, ``Guidance for Industry
for the Submission of an Environmental Assessment in Human Drug
Applications and Supplements'' (61 FR 1031). The guidance, prepared by
CDER, is intended to assist industry by providing guidance on how to
prepare EA's for submission to CDER as part of NDA's, antibiotic
applications, ANDA's, abbreviated antibiotic applications, and IND's.
This guidance will be amended to reflect the final regulations and
categorical exclusions and to include biologic products subject to
licensure under the PHS Act. The guidance document employs a tiered
approach to testing and accepts the use of test methods recognized and
recommended by competent authorities such as FDA (see e.g., FDA's EA
Technical Assistance Handbook), EPA (see 40 CFR parts 796 and 797) and
the Organization for Economic Co-operation and Development. Under the
proposed rule, this approach will continue to be acceptable.
The current formats in part 25 focus the environmental analysis on
the use and disposal from use of FDA-regulated articles but also
address production impacts. FDA proposes to maintain this focus in the
proposed revised regulations, but, for the following reasons, is
proposing to change the way it addresses production impacts. To address
the potential environmental impacts from production of FDA-regulated
articles, FDA currently requires a limited amount of information to
make sure that the article will be produced in compliance with
applicable emissions requirements. Specifically, the agency requires
that the following information be included in an EA: A list of the
substances expected to be emitted, the controls exercised, a citation
of applicable emissions requirements and statement of compliance with
these requirements, and a discussion of the effect the approval of the
petition will have on compliance with these requirements.
FDA recognizes, however, that Federal, State, and local
environmental protection agencies have the responsibility for issuing
regulations, permitting and licensing facilities, and enforcing
compliance with the requirements that these agencies have determined
are necessary to ensure adequate protection of the environment from
emissions from production operations. Regulating emissions from
production sites requires balancing between air, water, and solid waste
emissions for all production operations carried out at a production
site and in the region with consideration of the costs of compliance
and available technology that requires expertise found primarily in
Federal, State, and local environmental agencies. As required by
environmental regulations and/or as conditions of retaining licenses
and permits, manufacturers must obtain or modify permits and provide
information to these agencies when production operations are initiated
or changed. The information required to be provided to FDA regarding
production impacts and compliance with emission requirements is
information that is generally required to be provided to or is known by
other agencies whose responsibility is to monitor compliance.
FDA has reviewed hundreds of EA's in which information regarding
the manufacturing site, such as emitted substances and emission
controls, was provided. As a result of this review, FDA has found that
FDA-regulated articles produced in compliance with all applicable
emission requirements (e.g., Clean Air Act, Clean Water Act,
Occupational Safety and Health Act) will not significantly affect the
environment. Based on these findings, FDA has determined that it is no
longer necessary to review a company's compliance with Federal, State,
and local environmental laws and FDA is proposing to delete the
requirements for the submission of emission information for production
sites. Accordingly, under the proposed regulations, FDA will continue
to focus its environmental reviews on the use and disposal from use of
FDA-regulated articles, and FDA will no longer routinely require
submission of information regarding manufacturing sites or a
certification of compliance with Federal, State, and local emission
requirements. However, if information available to the agency or the
applicant establishes that the general or specific emission
[[Page 19488]]
requirements promulgated by Federal, State, or local environmental
protection agencies do not address unique emission circumstances and
the emissions may harm the environment, this would be sufficient
grounds for requesting manufacturing information in an EA. FDA
generally requires manufacturing information to be submitted as part of
applications or petitions for FDA-regulated articles. This information
will aid FDA in determining if a categorical exclusion request is
appropriate.
Proposed Sec. 25.40(a) includes additional information found in the
CEQ regulations to clarify that the EA shall include brief discussions
of the need for the proposal, alternatives, environmental impacts of
the proposed action, and a listing of agencies and persons consulted,
and include additional information to clarify the scope and focus of an
EA. Environmental documents shall concentrate on timely and significant
issues, not amass needless detail. To that end, the agency has included
some general information regarding the acceptability of using a tiered
testing scheme. A tiered testing scheme results in test termination
when sufficient data are available to assess the potential
environmental fate and effects of an FDA-regulated article in the
environment. Specific information regarding tiered testing will be
provided in guidance documents. Although the number of pages for any EA
may vary in relation to the complexity of the issues, generally they
should not exceed 30 pages, not including test reports and data.
The agency is proposing to add Sec. 25.40(b) to clarify that CEQ
regulations (40 CFR 1506.5(b)) place ultimate responsibility on FDA for
the scope and content of environmental analyses. Thus, FDA may require
additional information from applicants or may itself include additional
information in environmental documents (EA's, FONSI's, or EIS's) when
warranted. Proposed Sec. 25.40(c) would include information found in
current Sec. 25.30(a) and encourages applicants or petitioners who
submit EA's to FDA to consult with FDA regarding the appropriate scope
and content for EA's for the requested action. Proposed Sec. 25.40(d)
discusses incorporation of information in an EA by reference.
Proposed Sec. 25.41 would include information on FONSI's that is
found in current Sec. 25.32(a) and (c). The agency is proposing to
delete the language on notices of intent and draft, final, and
supplemental EIS's, found in current Sec. Sec. 25.33 and 25.34, because
the CEQ regulations describe the process for determining the scope of
an EIS and provide detailed requirements for the preparation of draft
and final EIS's. Thus, this information is duplicative and unnecessary
in FDA regulations (40 CFR 1501.7 and part 1502).
Proposed Sec. 25.42 would describe the subject matter that needs
to be discussed in an EIS and references the CEQ regulations governing
the requirements for preparation of an EIS. Proposed Sec. 25.42(c)
fulfills the CEQ requirement under 40 CFR 1502.9(c) that FDA adopt
procedures for introducing a supplement into its administrative record.
The agency is proposing to add new Sec. 25.43 to clarify the
agency's existing responsibility under the CEQ regulations to prepare a
concise public record of decision for cases requiring EIS's (40 CFR
1505.2).
Proposed Sec. 25.44 would include information found in current
Sec. 25.10(b), describing the responsibilities of lead and cooperating
agencies. The agency is proposing to delete duplicative and unnecessary
information on lead and cooperating agencies that is already found in
the CEQ regulations, and to delete the first sentence in current
Sec. 25.10(b) because it is self-evident that FDA will be the lead
agency for programs administered by FDA.
Proposed Sec. 25.45 would include information from current
Sec. 25.42, describing who the responsible agency official will be and
his or her responsibilities. The agency is proposing to remove
information in current Sec. 25.42 that is duplicative of requirements
already found in CEQ regulations.
E. Subpart E--Public Participation and Notification of Environmental
Documents-
The proposed rule would improve the usefulness and readability of
the regulations by reorganizing current subpart D of part 25, ``agency
decisionmaking'' (now proposed ``Public Participation and Notification
of Environmental Documents'') by deleting unnecessary information that
is duplicative of requirements found in the CEQ regulations, and, as
discussed above, moving information to other relevant sections.
Proposed subpart E would now address public participation in the NEPA
process and clarify circumstances under which environmental documents
will publicly be disclosed. These revisions are consistent with our
responsibilities under the CEQ regulations and under Executive Order
12898, Federal Actions to Address Environmental Justice in Minority
Populations and Low Income Populations, February 11, 1994.
CEQ regulations require that agency procedures ensure full
compliance with NEPA to the extent possible, unless existing law
applicable to the agency's operations expressly prohibits or makes
compliance impossible (40 CFR 1500.6). Proposed Sec. 25.50 clarifies
that laws governing public disclosure may limit FDA's ability to comply
with NEPA and CEQ regulations.
Proposed Sec. 25.51(a) and (b), public disclosure of FONSI's and
EA's, would include the public disclosure information found in current
Sec. 25.30(b) and 25.41(b). The proposed rule would move the
information relating to statutory timeframes from current Sec. 25.40(c)
to proposed Sec. 25.51(b)(1).
Proposed Sec. 25.52 would add new information relating to the
public disclosure of EIS's.
F. Subpart F--Other Requirements
Current subpart E will be renumbered as subpart F. The agency is
not proposing to amend this subpart.
IV. Environmental Impact Considerations
The agency has determined under current 21 CFR 25.24(a)(8) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, neither
an EA nor an EIS is required.
V. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354), and
under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts and equity). The Regulatory
Flexibility Act requires agencies to analyze regulatory options that
would minimize any significant impact of a rule on small entities. The
Unfunded Mandates Reform Act requires (in section 202) that agencies
prepare an assessment of anticipated costs and benefits before
proposing any rule that may result in an annual expenditure by State,
local, and tribal governments, in the aggregate, or by the private
sector, of $100,000,000 (adjusted annually for inflation). That act
also requires (in section 205) that the agency identify and
[[Page 19489]]
consider a reasonable number of regulatory alternatives and from those
alternatives select the least costly, most cost effective, or least
burdensome alternative that achieves the objective of the rule. The
following analysis demonstrates that this proposed rule is consistent
with the principles set forth in the Executive Order and in these two
statutes. The proposed rule is not an economically significant
regulatory action under Executive Order 12866.
Based on the approximate number of EA's that FDA currently
receives each year and the resources needed to prepare them, the agency
estimates that the proposed reduced requirements for submitting EA's
will result in an annual cost savings to industry of approximately
$15.7 million. The basis for this estimate is as follows:
Human pharmaceuticals: Approximately 125 EA's related to human
pharmaceuticals would be eliminated annually under the proposal. About
one-half of these are abbreviated EA's; the remainder are full
assessments. FDA assumes that the average cost of preparing an
abbreviated assessment was approximately $40,000, while the average
cost of a full assessment was approximately $200,000. These assumptions
yield a cost savings of about $2.5 million for abbreviated EA's and
$12.5 million for full EA's, for a total savings to industry from the
reduced requirements of EA's relating to human pharmaceuticals of
approximately $15 million per year.
Veterinary products: The proposed changes would eliminate
approximately 37 abbreviated EA's for veterinary products each year, at
an average cost of approximately $5,000 each. About 77 brief
submissions, which currently require categorical exclusion criteria
review, would also be eliminated; these cost an estimated $300 each to
prepare. Total cost savings to the veterinary products industry under
the proposal would thus be approximately $208,000 per year.
Food products: About 36 EA's per year received by CFSAN would be
eliminated under the proposal. Approximately 28 of these would have
been abbreviated EA's and 8 would have been full assessments under
current rules. FDA estimates that the cost of producing most
abbreviated EA's for CFSAN is approximately $2,500 and the average cost
of producing a full EA is approximately $50,000. These assumptions
imply an annual cost savings of approximately $70,000 for abbreviated
EA's and $400,000 for full EA's, for a total annual savings to the
foods industry of approximately $470,000.
In addition to these savings to industry, the proposed changes
would improve FDA efficiency by eliminating agency review costs of
approximately $1 million per year.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
of small entities. Because these regulations will not impose
significant new costs on any firms, the agency certifies that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
VI. Paperwork Reduction Act of 1995
This proposed rule contains reporting requirements that are
subject to public comment and review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
and 3507). Therefore, in accordance with 5 CFR part 1320, a description
of reporting requirements with an estimate of the annual collection of
information burden is given below by cross reference to existing FDA
clearance submissions previously approved by OMB which this proposed
rule affects.
FDA is soliciting comments to: (1) Evaluate whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (2) evaluate the accuracy of the agency's
estimate of the proposed collection of information; (3) evaluate the
quality, utility, and clarity of the information to be collected; and
(4) minimize the burden of the collection of information on those who
are to respond.
Title: National Environmental Policy Act; Policies and Procedures.
Description: FDA has previously issued regulations that implement
NEPA (part 25). The proposed rule would reduce the number of NEPA
evaluations by providing for categorical exclusions for additional
classes of actions that do not individually or cumulatively have a
significant effect on the human environment and for which, therefore,
neither an EIS nor an EA is required. FDA is also proposing to amend
these regulations to ensure that the NEPA procedures are more concise
and understandable to the public and to reflect current FDA policy with
respect to environmental considerations. This proposed rule is in
response to initiatives announced in the President's National
Performance Reports, ``Reinventing Drug and Medical Device
Regulations,'' April 1995, and ``Reinventing Food Regulations,''
January 1996.
Description of Respondents: Persons and businesses, including small
businesses.
Estimated Annual Reporting and Recordkeeping Burden: The estimated
burden associated with the information collection requirements for this
proposed rule will be recognized in the individual FDA clearances where
NEPA considerations apply. Listed below are those clearances affected
by this regulation, including the section of title 21 CFR, the title,
and the OMB approval number:
Section 10.30, Citizen Petitions, 0910-0183; Sec. 71.1, Color
Additive Petitions, 0910-0185; Sec. 170.35, Affirmation of Generally
Recognized As Safe (GRAS) Status, 0910-0132; Sec. 101.12, Reference
amounts customarily consumed per eating occasion, 0910-0286;
Sec. 101.69, Petitions for nutrient content claims, 0910-0288;
Sec. 101.70, Petitions for health claims, 0910-0287; Sec. 170.39,
Threshold of regulation for substances used in food-contact articles,
0910-0298; Sec. 171.1, Food Additive Petitions, 0910-0016; Sec. 312.23,
Conditions for Exemption of New Drugs for Investigational Use, 0910-
0014; Sec. 511.1, New Animal Drugs for Investigational Use Exempt From
Section 512(a) of the Act, 0910-0117; Sec. 514.1, New Animal Drug
Applications, 0910-0032; Sec. 514.8, Supplemental New Animal Drug
Applications, 0910-0032; Sec. 571.1, Food Additive Petitions, 0910-
0016; Sec. 601.2 Product Licenses-Procedures for Filing, 0910-0124;
Sec. 812.20, Investigational Device Exemptions Application, 0910-0078.
The proposed rule would reduce these information collections that
have already been reviewed and approved by the OMB. Reporting burdens
imposed by current part 25 are approved by OMB through December 31,
1997 (see OMB control number 0910-0190, ``National Environmental Policy
Act; Policy and Procedures--21 CFR Part 25'').
The agency has submitted copies of the proposed rule to OMB for
its review of these reporting requirements. Interested persons are
requested to send comments regarding information collection by May 3,
1996, to the Office of Information and Regulatory Affairs, OMB (address
above).
List of Subjects in 21 CFR Part 25
Environmental impact statements, Foreign relations, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and authority
[[Page 19490]]
delegated to the Commissioner of Food and Drugs, it is proposed that 21
CFR part 25 be revised to read as follows:
PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS
Subpart A--General Provisions
Sec.
25.1 Purpose.
25.5 Terminology.
25.10 Policies and NEPA planning.
Subpart B--Agency Actions Requiring Environmental Consideration
25.15 General procedures.
25.16 Public health and safety emergencies.
25.20 Actions requiring preparation of an environmental
assessment.
25.21 Extraordinary circumstances.
25.22 Actions requiring preparation of an environmental impact
statement.
Subpart C--Categorical Exclusions
25.30 General.
25.31 Human drugs and biologics.
25.32 Foods, food additives, and color additives.
25.33 Animal drugs.
25.34 Devices and electronic products.--
Subpart D--Preparation of Environmental Documents
25.40 Environmental assessments.-
25.41 Findings of no significant impact.
25.42 Environmental impact statements.
25.43 Records of decision.-
25.44 Lead and cooperating agencies.
25.45 Responsible agency official.
Subpart E--Public Participation and Notification of Environmental
Documents-
25.50 General information.
25.51 Environmental assessments and findings of no significant -
impact.
25.52 Environmental impact statements.-
Subpart F--Other Requirements
25.60 Environmental effects abroad of major agency actions.
Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321-393); secs. 351, 354-361 of the Public Health
Service Act (42 U.S.C. 262, 263b-264); 42 U.S.C. 4321, 4332; 40 CFR
parts 1500-1508; E.O. 11514, 3 CFR 1966-1970 Comp., p. 902, as
amended by E.O. 11991, 3 CFR 1977 Comp., p. 123; E.O. 12114, 3 CFR
1979 Comp., p. 356.
Subpart A--General Provisions
Sec. 25.1 Purpose.
The National Environmental Policy Act of 1969 (NEPA), as amended,
directs that, to the fullest extent possible, the policies,
regulations, and public laws of the United States shall be interpreted
and administered in accordance with the policies set forth in NEPA. All
agencies of the Federal Government shall comply with the procedures in
section 102(2) of NEPA except where compliance would be inconsistent
with other statutory requirements. The regulations in this part
implement section 102(2) of NEPA in a manner that is consistent with
FDA's authority under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act. This part also supplements the regulations
for implementing the procedural provisions of NEPA that were published
by the Council on Environmental Quality (CEQ) in 40 CFR Parts 1500
through 1508 and the procedures included in the ``HHS General
Administration Manual, Part 30: Environmental Protection'' (45 FR 76519
to 76534, November 19, 1980).
Sec. 25.5 Terminology.
(a) Definitions that apply to the terms used in this part are set
forth in the CEQ regulations under 40 CFR part 1508. The terms and the
sections of 40 CFR part 1508 in which they are defined follow:
(1) Categorical exclusion (40 CFR 1508.4).
(2) Cooperating agency (40 CFR 1508.5).
(3) Cumulative impact (40 CFR 1508.7).
(4) Effects (40 CFR 1508.8).
(5) Environmental assessment (EA) (40 CFR 1508.9).
(6) Environmental document (40 CFR 1508.10).
(7) Environmental impact statement (EIS) (40 CFR 1508.11).
(8) Federal agency (40 CFR 1508.12).
(9) Finding of no significant impact (40 CFR 1508.13).
(10) Human environment (40 CFR 1508.14).
(11) Lead agency (40 CFR 1508.16).
(12) Legislation (40 CFR 1508.17).
(13) Major Federal action (40 CFR 1508.18).
(14) Mitigation (40 CFR 1508.20).
(15) NEPA process (40 CFR 1508.21).
(16) Notice of intent (40 CFR 1508.22).
(17) Proposal (40 CFR 1508.23).
(18) Scope (40 CFR 1508.25).
(19) Significantly (40 CFR 1508.27).
(b) The following terms are defined solely for the purpose of
implementing the supplemental procedures provided by this part and are
not necessarily applicable to any other statutory or regulatory
requirements:-
(1) Abbreviated application applies to an abbreviated new drug
application, an abbreviated antibiotic application, and an abbreviated
new animal drug application.
(2) Active moiety means the molecule or ion, excluding those
appended portions of the molecule that cause the drug to be an ester,
salt (including a salt with hydrogen or coordination bonds), or other
noncovalent derivative (such as a complex chelate or clathrate) of the
molecule responsible for the physiological or pharmacological action of
the drug substance.
(3) Agency means the Food and Drug Administration (FDA).
(4) Increased use of a drug or biologic product may occur if the
drug will be administered at higher dosage levels, for longer duration
or for different indications than were previously in effect, or if the
drug is a new molecular entity. New molecular entity means a drug for
which the active moiety (present as the unmodified (parent) compound,
or an ester or a salt, clathrate, or other noncovalent derivative of
the base (parent) compound) has not been previously approved or
marketed in the United States for use in a drug product, either as a
single ingredient or as part of a combination product or as part of a
mixture of stereoisomers. The term ``use'' also encompasses disposal of
FDA-regulated articles by consumers.
(5) Responsible agency official means the agency decision maker
designated in part 5 of this chapter.
(c) The following acronyms are used in this part:
(1) CEQ--Council on Environmental Quality.
(2) CGMP--Current good manufacturing practice.
(3) EA--Environmental assessment.
(4) EIS--Environmental impact statement.
(5) The act--Federal Food, Drug, and Cosmetic Act.
(6) FIFRA--Federal Insecticide, Fungicide, and Rodenticide Act.
(7) FONSI--Finding of no significant impact.
(8) GLP--Good laboratory practice.
(9) GRAS--Generally recognized as safe.
(10) HACCP--Hazard analysis critical control point.
(11) IDE--Investigational device exemption.
(12) IND--Investigational new drug application.
(13) INAD--Investigational new animal drug application.
(14) NADA--New animal drug application.
(15) NDA--New drug application.
(16) NEPA--National Environmental Policy Act of 1969.-
(17) PDP--Product development protocol.
(18) PMA--Premarket approval application.-
Sec. 25.10 Policies and NEPA planning.
(a) All FDA's policies and programs will be planned, developed,
and implemented to achieve the policies declared by NEPA and required
by CEQ's regulations to ensure responsible
[[Page 19491]]
stewardship of the environment for present and future generations.
(b) Assessment of environmental factors continues throughout
planning and is integrated with other program planning at the earliest
possible time to ensure that planning and decisions reflect
environmental values, to avoid delays later in the process, and to
avoid potential conflicts.
(c) For actions initiated by the agency, the NEPA process will
begin when the agency action under consideration is first identified.
For actions initiated by applicants or petitioners, NEPA planning
begins when FDA receives a submission from an applicant or petitioner
seeking action by FDA. FDA may issue a public call for environmental
data or otherwise consult with affected individuals or groups when a
contemplated action in which it is or may be involved poses potential
significant environmental effects.
(d) Environmental documents shall concentrate on timely and
significant issues, not amass needless detail.
(e) If a proposed action for which an EIS will be prepared
involves possible environmental effects that are required to be
considered under statutes or Executive Orders other than those referred
to under ``Authority'' in this part, these effects shall be considered
in the NEPA review, consistent with 40 CFR 1502.25 and the Department
of Health and Human Services' General Administration Manual, part 30.
Subpart B--Agency Actions Requiring Environmental Consideration
Sec. 25.15 General procedures.
(a) All applications or petitions requesting agency action require
the submission of an EA or a claim of categorical exclusion. A claim of
categorical exclusion shall include a certification of compliance with
the categorical exclusion criteria and shall certify that to the
applicant's knowledge, no extraordinary circumstances exist. Failure to
submit an adequate EA for an application or petition requesting action
by the agency of a type specified in Sec. 25.20, unless the agency can
determine that the action qualifies for exclusion under Secs. 25.30,
25.31, 25.32, 25.33, or 25.34, is sufficient grounds for FDA to refuse
to file or approve the application or petition.
(b) The responsible agency officials will evaluate the information
contained in the EA to determine whether it is accurate and objective,
whether the proposed action may significantly affect the quality of the
human environment, and whether an EIS will be prepared. If significant
effects requiring the preparation of an EIS are identified, FDA will
prepare an EIS for the action in accordance with the procedures in
subparts D and E of this part. If significant effects requiring the
preparation of an EIS are not identified, resulting in a decision not
to prepare an EIS, the responsible agency official will prepare a FONSI
in accordance with Sec. 25.41.
(c) Classes of actions that individually or cumulatively do not
significantly affect the quality of the human environment ordinarily
are excluded from the requirement to prepare an EA or an EIS. The
classes of actions that qualify as categorical exclusions are set forth
in Secs. 25.30, 25.31, 25.32, 25.33, or 25.34.
(d) A person submitting an application or petition of a type
subject to categorical exclusion under Secs. 25.30, 25.31, 25.32,
25.33, or 25.34, or proposing to dispose of an article as provided in
Secs. 25.30(d) or 25.32(h), is not required to submit an EA if the
person certifies that the action requested qualifies for a categorical
exclusion, citing the particular categorical exclusion that is claimed,
and certifies that to the applicant's knowledge, no extraordinary
circumstances exist.
Sec. 25.16 Public health and safety emergencies.
There are certain regulatory actions that, because of their
immediate importance to the public health or safety, may make adherence
to the procedural provisions of NEPA and CEQ's regulations impossible.
For such actions, the responsible agency official shall consult with
CEQ about alternative arrangements before the action is taken, or after
the action is taken, if time does not permit prior consultation with
CEQ.
Sec. 25.20 Actions requiring preparation of an environmental
assessment.
Any proposed action of a type specified in this section ordinarily
requires at least the preparation of an EA, unless it is an action in a
specific class that qualifies for exclusion under Secs. 25.30, 25.31,
25.32, 25.33, or 25.34:
(a) Major recommendations or reports made to Congress on proposals
for legislation in instances where the agency has primary
responsibility for the subject matter involved.
(b) Destruction or other disposition of articles condemned after
seizure or whose distribution or use has been enjoined, unless
categorically excluded in Secs. 25.30(d) or 25.32(h).
(c) Destruction or other disposition of articles following
detention or recall at agency request, unless categorically excluded in
Secs. 25.30(d) or 25.32(h).
(d) Disposition of FDA laboratory waste materials, unless
categorically excluded in Sec. 25.30(m).
(e) Intramural and extramural research supported in whole or in
part through contracts, other agreements, or grants, unless
categorically excluded in Sec. 25.30(e) or (f).
(f) Establishment by regulation of labeling requirements, a
standard, or a monograph, unless categorically excluded in
Secs. 25.30(k) or 25.31(a), (b), (c), (h), (i), or (j), or 25.32(a) or
(p).
(g) Issuance, amendment, and enforcement of FDA regulations, or an
exemption or variance from FDA regulations, unless categorically
excluded in Secs. 25.30(h), (i), or (j), or 25.32(e), (g), (n), or (p).
(h) Withdrawal of existing approvals of FDA-approved articles,
unless categorically excluded in Secs. 25.31(d) or (k), 25.32(m), or
25.33(g) or (h).
(i) Approval of food additive petitions and color additive
petitions, approval of requests for exemptions for investigational use
of food additives, and granting of requests for exemption from
regulation as a food additive, unless categorically excluded in
Sec. 25.32(b), (c), (i), (j), (k), (l), (o), (q), or (r).
(j) Establishment of a tolerance for unavoidable poisonous or
deleterious substances in food or in packaging materials to be used for
food.--
(k) Affirmation of a food substance as GRAS for humans or animals,
on FDA's initiative or in response to a petition, under part 182, 184,
186, or 582 of this chapter and establishment or amendment of a
regulation for a prior-sanctioned food ingredient, as defined in
Secs. 170.3(l) and 181.5(a) of this chapter, unless categorically
excluded in Sec. 25.32(f), (k), or (r).
(l) Approval of NDA's, abbreviated applications, applications for
marketing approval for marketing of a biologic product, supplements to
such applications, and actions on IND's, unless categorically excluded
in Sec. 25.31(a), (b), (c), (e), or (l).
(m) Approval of NADA's, abbreviated applications, supplements, and
actions on INAD's, unless categorically excluded under Sec. 25.33(a),
(c), (d), or (e).
(n) Approval of PMA's for medical devices, notices of completion
of PDP's for medical devices, authorizations to commence clinical
investigation under an approved PDP, or applications for an IDE, unless
categorically excluded in Sec. 25.34.
Sec. 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4, FDA will require at least an EA
for any specific action that ordinarily would be
[[Page 19492]]
excluded if extraordinary circumstances indicate that the specific
proposed action may significantly affect the quality of the human
environment (see 40 CFR 1508.27 for examples of significant impacts).
Examples of such extraordinary circumstances include:
(a) Actions for which available data establish that, at the
expected level of exposure, there is the potential for serious harm to
the environment; and
(b) Actions that adversely affect a species or the critical
habitat of a species determined under the Endangered Species Act or the
Convention on International Trade in Endangered Species of Wild Flora
and Fauna to be endangered or threatened or wild flora or fauna that
are entitled to special protection under some other Federal law.
Sec. 25.22 Actions requiring the preparation of an environmental
impact statement.
(a) There are no categories of agency actions that routinely
significantly affect the quality of the human environment and that
therefore ordinarily require the preparation of an EIS.
(b) EIS's are prepared for agency actions when evaluation of data
or information in an EA or otherwise available to the agency leads to a
finding by the responsible agency official that a proposed action may
significantly affect the quality of the human environment.
Subpart C--Categorical Exclusions
Sec. 25.30 General.
The classes of actions listed in this section and Secs. 25.31
through 25.34 are categorically excluded and, therefore, ordinarily do
not require the preparation of an EA or an EIS:
(a) Routine administrative and management activities, including
inspections, and issuance of field compliance programs, program
circulars, or field investigative assignments.
(b) Recommendation for an enforcement action to be initiated in a
Federal court.
(c) Agency requests for initiation of recalls.
(d) Destruction or disposition of any FDA-regulated article
condemned after seizure or the distribution or use of which has been
enjoined or following detention or recall at agency request if the
method of destruction or disposition of the article, including
packaging material, is in compliance with all Federal, State, and local
requirements.
(e) Extramural contracts, other agreements, or grants for
statistical and epidemiological studies, surveys and inventories,
literature searches, and report and manual preparation, or any other
studies that will not result in the production or distribution of any
substance and, therefore, will not result in the introduction of any
substance into the environment.
(f) Extramural contracts, other agreements, and grants for
research for such purposes as to develop analytical methods or other
test methodologies.
(g) Activities of voluntary Federal-State cooperative programs,
including issuance of model regulations proposed for State adoption.
(h) Issuance, amendment, or revocation of procedural or
administrative regulations and guidelines, including procedures for
submission of applications for product development, testing and
investigational use, and approval.
(i) Corrections and technical changes in regulations.
(j) Issuance of CGMP regulations, HACCP regulations, establishment
standards, emergency permit control regulations, GLP regulations, and
issuance or denial of permits, exemptions, variances, or stays under
these regulations.
(k) Establishment or repeal by regulation of labeling requirements
for marketed articles if there will be no increase in the existing
levels of use or change in the intended uses of the product or its
substitutes.
(l) Routine maintenance and minor construction activities such as:
(1) Repair to or replacement of equipment or structural components
(e.g., door, roof, or window) of facilities controlled by FDA;
(2) Lease extensions, renewals, or succeeding leases;
(3) Construction or lease construction of 10,000 square feet or
less of occupiable space;
(4) Relocation of employees into existing owned or currently
leased space;
(5) Acquisition of 20,000 square feet or less of occupiable space
in a structure that was substantially completed before the issuance of
solicitation for offers; and
(6) Acquisition of between 20,000 square feet and 40,000 square
feet of occupiable space if it constitutes less than 40 percent of the
occupiable space in a structure that was substantially completed before
the solicitation for offers.
(m) Disposal of low-level radioactive waste materials (as defined
in the Nuclear Regulatory Commission regulations at 10 CFR 61.2) and
chemical waste materials generated in the laboratories serviced by the
contracts administered by FDA, if the waste is disposed of in
compliance with all applicable Federal, State, and local requirements.
Sec. 25.31 Human drugs and biologics.
The classes of actions listed in this section are categorically
excluded and, therefore, ordinarily do not require the preparation of
an EA or an EIS:
(a) Action on an NDA, abbreviated application, or a supplement to
such application, or action on an OTC monograph, if the action does not
increase the use of the active moiety.
(b) Action on an NDA, abbreviated application, or a supplement to
such application, or action on an OTC monograph, if the action
increases the use of the active moiety, but the concentration of the
substance in the environment will be below 1 part per billion.
(c) Action on an NDA, abbreviated application, application for
marketing approval of a biologic product, or a supplement to such
application, or action on an OTC monograph, for substances that occur
naturally in the environment when the action does not alter
significantly the concentration or distribution of the substance, its
metabolites, or degradation products in the environment.
(d) Withdrawal of approval of an NDA or an abbreviated
application.
(e) Action on an IND.
(f) Testing and certification of batches of an antibiotic or
insulin.
(g) Testing and release by the Center for Biologics Evaluation and
Research of lots or batches of a licensed biologic product.
(h) Issuance, revocation, or amendment of a monograph for an
antibiotic drug.
(i) Establishment of bioequivalence requirements for a human drug
or a comparability determination for a biologic product subject to
licensing.
(j) Issuance, revocation, or amendment of a standard for a
biologic product.
(k) Revocation of a license for a biologic product.
(l) Action on an application for marketing approval for marketing
of a biologic product for transfusable human blood or blood components
and plasma.
Sec. 25.32 Foods, food additives, and color additives.
The classes of actions listed in this section are categorically
excluded and, therefore, ordinarily do not require the preparation of
an EA or an EIS:
(a) Issuance, amendment, or repeal of a food standard.
(b) Action on a request for exemption for investigational use of a
food additive if the food additive to be shipped under
[[Page 19493]]
the request is intended to be used for clinical studies or research.
(c) Approval of a color additive petition to change a
provisionally listed color additive to permanent listing for use in
food, drugs, devices, or cosmetics.
(d) Testing and certification of batches of a color additive.
(e) Issuance of an interim food additive regulation.
(f) Affirmation of a food substance as GRAS for humans or animals
on FDA's initiative or in response to a petition, under parts 182, 184,
186, or 582 of this chapter, and establishment or amendment of a
regulation for a prior-sanctioned food ingredient, as defined in
Secs. 170.3(l) and 181.5(a) of this chapter, if the substance or food
ingredient is already marketed in the United States for the proposed
use.
(g) Issuance and enforcement of regulations relating to the
control of communicable diseases or to interstate conveyance sanitation
under parts 1240 and 1250 of this chapter.
(h) Approval of a request for diversion of adulterated or
misbranded food for humans or animals to use as animal feeds.
(i) Approval of a food additive petition or the granting of a
request for exemption from regulation as a food additive under
Sec. 170.39 of this chapter when the additive is present in finished
food-packaging material at not greater than 5 percent-by-weight and is
also a functional component of the finished packaging material.
(j) Approval of a food additive petition or the granting of a
request for exemption from regulation as a food additive under
Sec. 170.39 of this chapter when the additive is to be used as a
component of a food-contact surface of permanent or semipermanent
equipment or of another food-contact article intended for repeated use.
(k) Approval of a food additive, color additive, or GRAS petition
for substances added directly to food that are intended to remain in
food through ingestion by consumers and that are not intended to
replace macronutrients in food.
(l) Approval of a petition for color additives used in contact
lenses, sutures, filaments used as supporting haptics in intraocular
lenses, bone cement, and in other FDA-regulated products having
similarly low levels of use.
(m) Action to prohibit or otherwise restrict or reduce the use of
a substance in food, food packaging, or cosmetics.
(n) Issuance, amendment, or revocation of a regulation pertaining
to infant formulas.
(o) Approval of a food additive petition for the intended
expression product(s) present in food derived from new plant varieties.
(p) Issuance, amendment, or revocation of a regulation in response
to a reference amount petition as described in Sec. 101.12(h) of this
chapter, a nutrient content claim petition as described in Sec. 101.69
of this chapter, a health claim petition as described in Sec. 101.70 of
this chapter, or a petition pertaining to the label declaration of
ingredients as described in Sec. 101.103 of this chapter.
(q) Approval of a food additive petition or the granting of a
request for an exemption from regulation as a food additive under
Sec. 170.39 of this chapter for a substance registered by the
Environmental Protection Agency under FIFRA for the same use requested
in the petition.
(r) Approval of a food additive, color additive, or GRAS
affirmation petition for a substance that occurs naturally in the
environment, when the action does not alter significantly the
concentration or distribution of the substance, its metabolites, or
degradation products in the environment.
Sec. 25.33 Animal drugs.
The classes of actions listed in this section are categorically
excluded and, therefore, ordinarily do not require the preparation of
an EA or an EIS:
(a) Action on an NADA, abbreviated application, or supplement to
such applications, if the action does not increase the use of the drug.
Actions to which this categorical exclusion applies include:
(1) An animal drug to be marketed under the same conditions of
approval as a previously approved animal drug;
(2) A combination of previously approved animal drugs;
(3) A new premix or other formulation of a previously approved
animal drug;
(4) Changes specified in Sec. 514.8(a)(5), (a)(6), or (d) of this
chapter;
(5) A change of sponsor;
(6) A previously approved animal drug to be contained in medicated
feed blocks under Sec. 510.455 of this chapter or as a liquid feed
supplement under Sec. 558.5 of this chapter; or
(7) Approval of a drug for use in animal feeds if such drug has
been approved under Sec. 514.2 or 514.9 of this chapter for other uses.
(b) [Reserved]
(c) Action on an NADA, abbreviated application, or a supplement for
substances that occur naturally in the environment when the action does
not alter significantly the concentration or distribution of the
substance, its metabolites, or degradation products in the environment.
(d) Action on an NADA, abbreviated application, or a supplement to
such applications, for:
(1) Drugs intended for use in nonfood animals;
(2) Anesthetics, both local and general, that are individually
administered;
(3) Nonsystemic topical and ophthalmic animal drugs;
(4) Drugs for minor species, including wildlife and endangered
species, when the drug has been previously approved for use in another
or the same species where similar animal management practices are used;
and
(5) Drugs intended for use under prescription or veterinarian's
order for therapeutic use.
(e) Action on an INAD.
(f) Action on an application submitted under section 512(m) of the
act.
(g) Withdrawal of approval of an NADA or an abbreviated NADA.
(h) Withdrawal of approval of a food additive petition that reduces
or eliminates animal feed uses of a food additive.
Sec. 25.34 Devices and electronic products.
The classes of actions listed in this section are categorically
excluded and, therefore, ordinarily do not require the preparation of
an EA or an EIS:
(a) Action on a device premarket notification submission under
subpart E of part 807 of this chapter.
(b) Classification or reclassification of a device under part 860
of this chapter.
(c) Issuance, amendment, or repeal of a standard for a class II
medical device or an electronic product, and issuance of exemptions or
variances from such a standard.
(d) Approval of a PMA or a notice of completion of a PDP or amended
or supplemental applications or notices for a class III medical device
if the device is of the same type and for the same use as a previously
approved device.
(e) Changes in the PMA or a notice of completion of a PDP for a
class III medical device that do not require submission of an amended
or supplemental application or notice.
(f) Issuance of a restricted device regulation if it will not
result in increases in the existing levels of use or changes in the
intended uses of the product or its substitutes.
(g) Action on an application for an IDE or an authorization to
commence a clinical investigation under an approved PDP.
(h) Issuance of a regulation exempting from preemption a
requirement of a State or political subdivision concerning a device, or
a denial of an application for such exemption.
[[Page 19494]]
Subpart D--Preparation of Environmental Documents
Sec. 25.40 Environmental assessments.-
(a) As defined by CEQ in 40 CFR 1508.9, an EA is a concise public
document that serves to provide sufficient evidence and analysis for an
agency to determine whether to prepare an EIS or a FONSI. The EA shall
include brief discussions of the need for the proposal, of alternatives
as required by section 102(2)(E) of NEPA, of the environmental impacts
of the proposed action and alternatives, and a listing of agencies and
persons consulted. An EA shall be prepared for each action not
categorically excluded in Secs. 25.30, 25.31, 25.32, 25.33, or 25.34.
The EA shall focus on relevant environmental issues and shall be a
concise, objective, and well-balanced document that allows the public
to understand the agency's decision. If potentially adverse
environmental impacts are identified for an action or group of related
actions, the EA shall discuss any reasonable alternative course of
action that offers less environmental risk or that is environmentally
preferable to the proposed action. The use of a scientifically
justified tiered testing approach, in which testing may be stopped when
the results suggest that no significant impact will occur, is an
acceptable approach.
(b) Generally, FDA requires an applicant to prepare an EA and make
necessary corrections to it. Ultimately, FDA is responsible for the
scope and content of EA's and may include additional information in
environmental documents when warranted.
(c) Information concerning the nature and scope of information
that an applicant or petitioner shall submit in an EA may be obtained
from the center or other office of the agency having responsibility for
the action that is the subject of the environmental evaluation.
Applicants and petitioners are encouraged to submit proposed protocols
for environmental studies for technical review by agency staff.
Applicants and petitioners also are encouraged to consult applicable
FDA EA guidance documents, which provide additional advice on how to
comply with FDA regulations.
(d) Consistent with 40 CFR 1500.4(j) and 1502.21, EA's may
incorporate by reference information presented in other documents that
are available to FDA and to the public.
(e) The agency evaluates the information contained in an EA and any
public input to determine whether it is accurate and objective, whether
the proposed action may significantly affect the quality of the human
environment, and whether an EIS or FONSI will be prepared. The
responsible agency official designated in part 5 of this chapter as
responsible for the underlying action examines the environmental risks
of the proposed action and the alternative courses of action, selects a
course of action, and ensures that any necessary mitigating measures
are implemented as a condition for approving the selected course of
action.
Sec. 25.41 Findings of no significant impact.
(a) As defined by the CEQ regulations (40 CFR 1508.13), a FONSI is
a document prepared by a Federal agency stating briefly why an action,
not otherwise excluded, will not significantly affect the human
environment and for which, therefore, an EIS will not be prepared. A
FONSI includes the EA or a summary of it and a reference to any other
related environmental documents.
(b) The agency official(s) responsible for approving the FONSI will
sign the document, thereby establishing that the official(s) approve(s)
the conclusion not to prepare an EIS for the action under
consideration.
Sec. 25.42 Environmental impact statements.
(a) As defined by CEQ regulations (40 CFR 1508.11) and section
102(2)(C) of NEPA, an EIS should be a clear, concise, and detailed
written statement describing:
(1) The environmental impacts of a proposed action;
(2) Any adverse effects that cannot be avoided if the action is
implemented;
(3) Alternatives to the action;
(4) The relationship between local short-term uses of the
environment and the maintenance and enhancement of long-term
productivity; and
(5) Any irreversible and irretrievable commitments of resources
that would be involved in the proposed action should it be implemented.
(b) The CEQ regulations (40 CFR 1501.7 and part 1502) describe the
process for determining the scope of an EIS and provide detailed
requirements for the preparation of draft and final EIS's. CEQ format
and procedures for preparing EIS shall be followed.
(c) Under the conditions prescribed in 40 CFR 1502.9, the agency
will prepare a supplement for a draft or final EIS and introduce the
supplement into the administrative record.
Sec. 25.43 Records of decisions.
(a) In cases requiring environmental impact statements, at the time
of its decision, the agency shall prepare a concise public record of
decision.
(b) The record of decision shall:
(1) State what the decision was;
(2) Identify and discuss alternatives considered by the agency in
reaching its decision;
(3) State whether all practicable means to avoid or minimize
environmental harm have been adopted, and if not, why not; and
(4) Discuss and implement any monitoring and enforcement program
necessary to affect mitigation.
Sec. 25.44 Lead and cooperating agencies.--
For actions requiring the preparation of an EIS, FDA and other
affected Federal agencies will agree which will be the lead agency and
which will be the cooperating agencies. The responsibilities of lead
agencies and cooperating agencies are described in the CEQ regulations
(40 CFR 1501.5 and 1501.6, respectively). If an action affects more
than one center within FDA, the Commissioner of Food and Drugs will
designate one of these units to be responsible for coordinating the
preparation of any required environmental documentation.
Sec. 25.45 Responsible agency official.
(a) The person designated in part 5 of this chapter as the
responsible agency official for the underlying action is responsible
for preparing environmental documents or ensuring that they are
prepared.
(b) The responsible agency official will weigh any environmental
impacts of each alternative course of action, including possible
mitigation measures, and will balance environmental impacts with the
agency's objectives in choosing an appropriate course of action. The
weighing of any environmental impacts of alternatives in selecting a
final course of action will be reflected in the agency's record of
formal decisionmaking as required by 40 CFR 1505.2.
Subpart E--Public Participation and Notification of Environmental
Documents
Sec. 25.50 General information.
(a) To the extent actions are not protected from disclosure by
existing law applicable to the agency's operation, FDA will involve the
public in preparing and implementing its NEPA procedures and will
provide public notice of NEPA-related hearings, public meetings, and
the availability of environmental documents.
(b) Many FDA actions involving investigations, review, and
approval of applications, and premarket notifications for human drugs,
animal drugs, biologic products, and devices are protected from
disclosure under the
[[Page 19495]]
Trade Secret Act, 18 U.S.C. 1905, and 301(j) of the act. These actions
are also protected from disclosure under FDA's regulations including
part 20, Secs. 312.130(a), 314.430(b), 514.11(b), 514.12(a), 601.50(a),
601.51(a), 807.95(b), 812.38(a), and 814.9(b) of this chapter. Even the
existence of applications for human drugs, animal drugs, biologic
products, and devices is protected from disclosure under these
regulations. Therefore, unless the existence of applications for human
drugs, animal drugs, biologic products, or premarket notification for
devices has been made publicly available, the release of the
environmental document before approval of human drugs, animal drugs,
biologic products, and devices is inconsistent with statutory
requirements imposed on FDA. Appropriate environmental documents,
comments, and responses will be included in the administrative record
to the extent allowed by applicable laws.
Sec. 25.51 Environmental assessments and findings of no significant -
impact.
(a) Data and information that are protected from disclosure by 18
U.S.C. 1905 or 21 U.S.C. 331(j) or 360j(c) shall not be included in the
portion of environmental documents that is made public. When such data
and information are pertinent to the environmental review of a proposed
action, an applicant or petitioner shall submit such data and
information separately in a confidential section and shall summarize
the confidential data and information in the EA to the extent possible.
(b) FONSI's and EA's will be available to the public in accordance
with 40 CFR 1506.6 as follows:
(1) When the proposed action is the subject of a notice of
proposed rulemaking or a notice of filing published in the Federal
Register, the notice shall state that no EIS is necessary and that the
FONSI and the EA are available for public inspection at FDA's Dockets
Management Branch. If the responsible agency official is unable to
complete environmental consideration of the proposed action before a
notice of filing of a food or color additive petition is required to be
published under the act, and if the subsequent environmental analysis
leads to the conclusion that no EIS is necessary, the Federal Register
document publishing the final regulation rather than the notice of
filing shall state that no EIS is necessary and that the FONSI and the
EA are available upon request and filed in FDA's Dockets Management
Branch.
(2) For actions for which notice is not published in the Federal
Register, the FONSI and the EA shall be made available to the public
upon request according to the procedures in 40 CFR 1506.6.
(3) For a limited number of actions, the agency may make the FONSI
and EA available for public review (including review by State and
areawide information clearinghouses) for 30 days before the agency
makes its final determination whether to prepare an EIS and before the
action may begin, as described in 40 CFR 1501.4(e). This procedure will
be followed when the proposed action is, or is closely similar to, one
that normally requires an EIS or when the proposed action is one
without precedent.
Sec. 25.52 Environmental impact statements.
(a) If FDA determines that an EIS is necessary for an action
involving investigations or approvals for drugs, animal drugs, biologic
products, or devices, an EIS will be prepared but will become available
only at the time of the approval of the product. Disclosure will be
made in accordance with 40 CFR 1506.6 and part 20 of this chapter. The
EIS will in all other respects conform to the requirements for EIS's as
specified in 40 CFR part 1502 and 1506.6(f).
(b) Comments on the EIS may be submitted after the approval of the
drug, animal drug, biologic product, and device. Those comments can
form the basis for the agency to consider beginning an action to
withdraw the approval of applications for a drug, animal drug, biologic
product, or to withdraw premarket notifications or premarket approval
applications for devices.
(c) In those cases where the existence of applications and
premarket notifications for drugs, animal drugs, biologic products, or
devices has already been disclosed before the agency approves the
action, the agency will make diligent effort (40 CFR 1506.6) to involve
the public in preparing and implementing the NEPA procedures for EIS's
while following its own disclosure requirements including those listed
in part 20, Secs. 312.130(b), 314.430(d), 514.11(d), 514.12(b),
601.51(d), 807.95(e), 812.38(b), and 814.9(d) of this chapter.
(d) Draft and final EIS's, comments, and responses will be
included in the administrative record and will be available from the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
Subpart F--Other Requirements
Sec. 25.60 Environmental effects abroad of major agency actions.
(a) In accordance with Executive Order 12114, ``Environmental
Effects Abroad of Major Federal Actions'' of January 4, 1979 (44 FR
1957, January 9, 1977), the responsible agency official, in analyzing
actions under his or her program, shall consider the environmental
effects abroad, including whether the actions involve:
(1) Potential environmental effects on the global commons and areas
outside the jurisdiction of any nation, e.g., oceans and the upper
atmosphere.
(2) Potential environmental effects on a foreign nation not
participating with or otherwise involved in an FDA activity.
(3) The export of products (or emissions) that in the United States
are prohibited or strictly regulated because their effects on the
environment create a serious public health risk.
(4) Potential environmental effects on natural and ecological
resources of global importance designated under the Executive Order.
(b) Before deciding on any action falling into the categories
specified in paragraph (a) of this section, the responsible agency
official shall determine in accordance with section 2-3 of the
Executive Order whether such actions may have a significant
environmental effect abroad.
(c) If the responsible agency official determines that an action
may have a significant environmental effect abroad, the responsible
agency official shall determine in accordance with section 2-4(a) and
(b) of the Executive Order, whether the subject action calls for:
(1) An EIS;
(2) A bilateral or multilateral environmental study; or
(3) A concise environmental review.
(d) In preparing environmental documents under this subpart, the
responsible official shall:
(1) Determine, as provided in section 2-5 of the Executive Order,
whether proposed actions are subject to the exemptions, exclusions, and
modification in contents, timing, and availability of documents.
(2) Coordinate all communications with foreign governments
concerning environmental agreements and other arrangements in
implementing the Executive Order.
Dated: April 17, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-10732 Filed 4-30-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-10665 Endangered and Threatened Wildlife and Plants; Proposed Establishment of a Nonessential Experimental Population of the Mexican Gray Wolf in Arizona and New Mexico
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19237-19248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10665]
=======================================================================
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
RIN 1018-AD07
Endangered and Threatened Wildlife and Plants; Proposed
Establishment of a Nonessential Experimental Population of the Mexican
Gray Wolf in Arizona and New Mexico
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Proposed rule.
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SUMMARY: The U.S. Fish and Wildlife Service (Service) proposes to
reintroduce the endangered Mexican gray wolf (Canis lupus baileyi) into
two designated recovery areas within the subspecies' probable historic
range. The Blue Range Wolf Recovery Area consists of the entire Apache
and Gila National Forests in east-central Arizona and west-central New
Mexico. The White Sands Wolf Recovery Area consists of all land within
the boundary of the White Sands Missile Range in south-central New
Mexico together with designated land immediately to the west. The
wolves reintroduced into these areas are classified as one nonessential
experimental population under section 10(j) of the Endangered Species
Act (Act) of 1973, as amended. The proposed rule sets forth management
directions and provides for limited allowable legal take of wolves
within a defined Mexican Wolf Experimental Population Area.
DATES: Comments from all interested parties must be received by July 1,
1996.
ADDRESSES: Send comments and materials concerning this proposal to the
Mexican Wolf Recovery Program, U.S. Fish and Wildlife Service, P.O. Box
1306, Albuquerque, New Mexico 87103-1306. Comments and materials
received will be available for public inspection, by appointment,
during normal business hours at the above address. Copies of the draft
Environmental Impact Statement or its summary can be obtained at this
address.
FOR FURTHER INFORMATION CONTACT: Mr. David R. Parsons (see ADDRESSES
section) at telephone 505/248-6920; or facsimile 505/248-6922.
SUPPLEMENTARY INFORMATION:
Background
Legislative: The Endangered Species Act Amendments of 1982, Pub. L.
97-304, made significant changes to the Act, including the creation of
section 10(j), which provides for the designation of specific
populations of listed species as ``experimental populations.'' Under
previous authorities of the Act, the Service was permitted to
reestablish (reintroduce) populations of a listed species into
unoccupied portions of its historic range for conservation and recovery
purposes. However, local opposition to reintroduction efforts, stemming
from concerns by some about potential restrictions, and prohibitions on
Federal and private activities contained in sections 7 and 9 of the
Act, reduced the effectiveness of reintroduction as a management tool.
Under section 10(j), a population of a listed species reestablished
outside its current range but within its probable historic range may be
designated as ``experimental,'' at the discretion of the Secretary of
Interior (Secretary), if reintroduction of the experimental population
furthers the conservation of the listed species. An experimental
population must be separate geographically from nonexperimental
populations of the same species. Designation of a population as
experimental increases the Service's management flexibility.
Additional management flexibility exists if the Secretary finds the
experimental population to be ``nonessential'' to the continued
existence of the species. For purposes of section 7 (except section
7(a)(1), which requires Federal agencies to use their authorities to
conserve listed species), nonessential experimental populations located
outside national wildlife refuge or national park lands are treated as
if they are proposed for listing. This means that Federal agencies are
under an obligation to confer (as if the species were only proposed for
listing) as opposed to consult (required for a listed species) on any
actions authorized, funded, or carried out by them that are likely to
jeopardize the continued existence of the species. Nonessential
experimental populations located on national wildlife refuge or
national park lands are treated as threatened, and formal consultation
may be required. Activities undertaken on private lands are not
affected by section 7 of the Act unless they are authorized, funded, or
carried out by a Federal agency.
Individual animals used in establishing an experimental population
can be removed from a source population if their removal is not likely
to jeopardize the continued existence of the species (see Findings
Regarding Reintroduction, below), and a permit has been issued in
accordance with 50 CFR Part 17.22.
The Mexican wolf was listed as an endangered subspecies on April
28, 1976 (41 FR 17742). The gray wolf species in North America south of
Canada was listed as endangered (except in Minnesota where it was
listed as threatened) without reference to subspecies on March 9, 1978
(43 FR 9607). The Mexican Wolf Recovery Plan was adopted by the
Directors of the Service and the Mexican Direccion General de la Fauna
Silvestre in 1982. The plan guides recovery efforts for the subspecies,
laying out a series of recommended actions. The recovery plan is
currently being revised, and the revised document will more precisely
define the points at which downlisting and delisting will occur.
Biological: This proposed experimental population rule addresses
the Mexican wolf (Canis lupus baileyi), an endangered subspecies of
gray wolf that was extirpated from the southwestern United States by
1970. The gray wolf (C. lupus) is native to most of North America north
of Mexico City. An exception is in the southeastern United States,
which was occupied by the red wolf (C. rufus). The gray wolf occupied
areas that supported populations of hooved mammals (ungulates), its
major food source.
The Mexican wolf historically occurred over much of New Mexico,
Arizona, Texas, and northern Mexico, mostly in or near forested,
mountainous terrain. Numbering in the thousands before European
settlement, the Mexican wolf declined rapidly when its reputation as a
livestock killer led to concerted eradication efforts. Other factors
contributing to its decline were commercial and recreational hunting
and trapping of wolves; killing of wolves by game managers on the
theory that more game animals would be available for hunters; habitat
alteration; and human safety concerns (although no documentation exists
of Mexican wolf attacks on humans).
The subspecies is now considered extirpated from its historic range
in the southwestern United States because no wild wolf has been
confirmed since 1970. Occasional sightings of ``wolves'' continue to be
reported from United States locations, but none have been confirmed
through clear evidence. Recent field research has revealed no confirmed
reports of wolves remaining in Mexico. Investigations are continuing.
[[Page 19238]]
When Mexican wolves were eradicated, their natural history was
poorly understood. Appendix A to the draft Environmental Impact
Statement provides life history and biological descriptions of Mexican
wolves to the extent they are known or can be inferred from historical
evidence, observations of captive Mexican wolves, and studies of gray
wolves in other geographic regions. (The draft Environmental Impact
Statement should be referred to for background and supporting
information and literature references on all aspects of this proposed
rule; see ADDRESSES section.)
Recovery efforts: The Mexican Wolf Recovery Plan's objective is to
conserve and ensure survival of the subspecies by maintaining a captive
breeding program and reestablishing a viable, self-sustaining
population of at least 100 Mexican wolves in a 5,000 square mile area
within the subspecies' historic range. (The recovery plan is currently
under revision.)
A captive breeding program was established in the 1970's with two
wild male Mexican wolves caught from 1977 to 1980 (from Durango and
Chihuahua, Mexico) and one wild pregnant female wolf caught in 1978
(from Durango, Mexico). Two additional captive populations were
determined in July 1995 to be pure Mexican wolves; each has two
founders. The captive population has increased to 139 as of March 1996;
114 are held at 23 facilities in the United States and 25 at five
facilities in Mexico. This population has been managed since 1990 for
maximum reproduction to support the proposed reintroduction effort. The
goal is to have at least 100 animals in the United States facilities
prior to any releases into the wild.
On April 20, 1992, the Service issued a ``Notice of Intent to
Prepare an Environmental Impact Statement on the Experimental
Reintroduction of Mexican Wolves (Canis lupus baileyi) into Suitable
Habitat within the Historic Range of the Subspecies'' (57 FR 14427).
This notice also announced the time and place of public scoping
meetings. The draft Environmental Impact Statement was released for
public review and comment on June 27, 1995 (60 FR 33224). The location
and times of 14 public meetings were also announced in this notice. In
September of 1995, the Service announced that three public hearings
would be held in October 1995 (60 FR 49628). All announced meetings and
hearings were held. The public comment period closed on October 31,
1995. Approximately 18,000 people have commented or expressed an
opinion on the draft Environmental Impact Statement. Following an
analysis of the public comments, a final Environmental Impact Statement
will be issued around July 1996.
The proposed Mexican wolf recovery actions and this proposed rule
were developed by the Service after consultation with representatives
of Federal, State, and other agencies, with potentially affected
private parties, and with wolf experts nationally. Public comments
received at and after scoping meetings for the draft Environmental
Impact Statement were considered. (See draft Environmental Impact
Statement, Chapter 1 section on Scoping and Chapter 5-Consultation and
Coordination.)
Mexican wolf recovery areas: The Service has determined that the
proposed reintroductions in the White Sands Wolf Recovery Area and the
Blue Range Wolf Recovery Area have the greatest potential for
successfully achieving the current recovery objective for Mexican
wolves. (See paragraph (j)(6) of the proposed rule and Figures 1 and 2
for precise boundaries of these areas. Chapters 2 and 3 of the draft
Environmental Impact Statement describe the selection of these two
areas and provide detailed descriptions of them.)
The two wolf recovery areas are within the Mexican wolf's probable
historic range. Both contain vast, relatively remote, and isolated
expanses of federally-managed land. Suitable wolf habitat containing
relatively abundant prey such as deer and elk is available. As the
Mexican wolf is considered extinct in the wild in the United States,
both areas are wholly separate geographically from any known,
naturally-occurring nonexperimental populations of wild wolves. A
larger Mexican Wolf Experimental Population Area, which also is wholly
separate geographically from any known, naturally-occurring
nonexperimental populations of wild wolves, is defined in the rule,
paragraph (j)(6), (see Figure 3). Mexican wolf recovery is not proposed
throughout this larger area. Its purpose is to establish that any wild
wolf found in this larger area is a member of the nonessential
experimental population, and therefore subject to the provisions of
this rule, and not an ``endangered'' status wolf with full protection
of the Act.
Reintroduction procedures: Male and female pairs from the captive
population will be selected for release based on genetics, reproductive
performance, behavioral compatibility, response to the adaptation
process, and other factors. Selected pairs will be moved to the
Service's captive wolf management facility on the Sevilleta National
Wildlife Refuge in central New Mexico where measures will be taken to
improve their adaptation to life in the wild.
Wolves will be reintroduced by a ``soft release'' approach designed
to reduce the likelihood of quick dispersal away from the release
areas. This involves holding the animals in pens on site for up to
several months in order to acclimate them and to increase their
affinity for the area. (The soft release approach is described in more
detail in Chapter 2 of the draft Environmental Impact Statement.) The
releases will begin in 1996 or as soon thereafter as feasible.
Approximately five family groups of captive raised Mexican wolves
will be released over a period of 3 years into the White Sands Wolf
Recovery Area, with the goal of reaching a long-term sustainable
subpopulation of 20 wolves by 1998. In the Blue Range Wolf Recovery
Area, approximately 14 family groups will be released over a period of
5 years, with the goal of reaching a long-term sustainable
subpopulation of 100 wild wolves by 2004. The proposed action is
flexible, using either the White Sands Wolf Recovery Area or the Blue
Range Wolf Recovery Area, or both, and in the order of their use.
Management of the reintroduced population: The proposed
nonessential experimental designation enables the Service to develop
measures for management of the population that are less restrictive
than the mandatory prohibitions that protect species with
``endangered'' status. This includes limited allowance of both
governmental and private take of individual wolves under narrowly
defined circumstances. Management flexibility is needed to make
reintroduction compatible with current and planned human activities,
such as livestock grazing and hunting, in the reintroduction area. It
is also critical to obtaining needed State, tribal, local, and private
cooperation. Thus, this flexibility will improve the likelihood of
success.
Reintroduction will occur under management plans that allow
dispersal by the new wolf subpopulations beyond the primary recovery
zones where they will be released, into the secondary recovery zones of
the two designated wolf recovery areas (see Figures 1 and 2). The
Service and cooperating agencies will not allow the wolves to establish
territories outside these wolf recovery area boundaries without
landowner consent on private or tribal lands within the Mexican Wolf
Experimental Population Area.
[[Page 19239]]
No measures are expected to be needed to isolate the experimental
population from naturally occurring populations because no Mexican
wolves are now known to occur in the wild. However, the Service will
attempt to take every reasonable step to ensure that no naturally
occurring wild population (see definition in Rule Glossary) that might
exist within the recovery areas (which is considered highly unlikely)
are affected by the reintroduction of captive-raised, nonessential
experimental wolves. Surveys for wolf sign in these areas will be
conducted prior to any reintroduction. If a naturally occurring wild
population is found within one or both of the designated wolf recovery
areas, the proposed reintroduction there would not go forward with such
wild wolves present. Further, if a naturally occurring wild population
is found within one or both of the designated wolf recovery areas
within 90 days after members of the experimental population are
initially released (which also is considered highly unlikely), all
wolves in the reintroduced sub-population in such recovery area(s)
would be removed and the reintroduction would not continue there. Such
a wild population would have full endangered status under the Act.
Identification and monitoring: Prior to placement in release pens,
the adult wolves will receive permanent identification marks and radio
collars. Pups will receive surgically implanted transmitters prior to
release and the pups will be recaptured and fitted with radio collars
when they are large enough. Wild-born pups of the reintroduced
population that are captured will be given a permanent identification
mark and radio collar.
The Service and cooperating agencies will measure the success or
failure of the reintroductions, and the effects of such success or
failure on the conservation and recovery of Mexican wolves, by
continuously monitoring, researching, and evaluating the status of
released wolves in the wild. The agencies will prepare periodic
progress reports, annual reports, and full evaluations after 3 and 5
years that will recommend continuation or termination of the
reintroduction effort. The reports will also evaluate whether, and how,
to use the second wolf recovery area, that is, the one not used
initially.
Findings regarding reintroduction: The Service finds that the
reintroduced experimental population is reasonably likely to become
established and survive in the wild within the Mexican wolf's probable
historic range. Under the proposed rule and based on available data,
the Service projects that the Blue Range Wolf Recovery Area
subpopulation will achieve the 1982 Mexican Wolf Recovery Plan goal of
100 wolves occupying 5,000 square miles by 2004.
The White Sands Wolf Recovery Area will support an estimated 20
wolves occupying 1,000 square miles by 1998. This likely would not be
an independently viable subpopulation. Nevertheless, a subpopulation in
this size range could be maintained through supplemental releases (or,
speculatively, by natural immigration of wolves from another nearby
population if one existed, e.g., from a reintroduced subpopulation in
the Blue Range Wolf Recovery Area). Even if the White Sands Wolf
Recovery Area subpopulation is not viable, per se, the Service finds
that, through monitoring and research, such a reintroduction would
provide vital information about the ecology and behavior of wild
Mexican wolves and about the ability of captive-raised gray wolves to
survive in the wild. A reintroduction there would provide a valuable
assessment of the soft release approach to reintroducing captive-raised
wolves. Further, wolves successfully reintroduced into the White Sands
Wolf Recovery Area could be used as release stock for future
reintroductions elsewhere, which would increase the likelihood of
success compared to using captive-raised wolves as release stock.
Some members of the experimental population are expected to die
during the reintroduction efforts after removal from the captive
population. The Service finds that even if the entire experimental
population died, this would not appreciably reduce the prospects for
future survival of the subspecies in the wild. That is, future
reintroductions still would be feasible even if the reintroductions
proposed here failed. The individual Mexican wolves selected for
release will be as genetically redundant with other members of the
captive population as possible, thus minimizing any adverse effects on
the genetic integrity of the remaining captive population. The Service
has detailed lineage information on each captive Mexican wolf. The
captive population is managed for the Service under the American Zoo
and Aquarium Association's Species Survival Plan program. The
Association maintains a Studbook and provides an expert advisor for
small population management.
Management of the demographic and genetic makeup of the population
is guided by the SPARKS computer program. Kinship values, which range
from zero to one, are a measure of the relatedness of an individual to
the rest of the population. Wolves with higher kinship values are
genetically well-represented in the population. Only those individuals
whose kinship values are above the mean for the captive population as a
whole will be used for release. In addition, the PEDPAC computer
program will be used to identify suitable release candidates by
examining the influence of removing an individual animal on the
survival of the founders' genes. This management approach will
adequately protect the genetic integrity of the captive population and
thus the continued existence of the subspecies. The United States
captive population of Mexican wolves has approximately doubled in the
last 3 years demonstrating the captive population's reproductive
potential to replace reintroduced wolves that die. In view of all these
safeguards the Service finds that the reintroduced population would not
be ``essential'' under 50 CFR 17.81(c)(2).
The Service finds that release of the experimental population will
further the conservation of the subspecies and of the gray wolf species
as a whole. Currently, no viable populations of the Mexican wolf
subspecies are known to exist in the wild. No wild populations of the
gray wolf species are known to exist in the United States south of
Montana, Minnesota, Wisconsin, and Michigan. (The Service is in the
process of reintroducing wild gray wolves from Canada into central
Idaho and Yellowstone National Park in Wyoming.) The Mexican wolf is
the most southerly and the most genetically distinct of all North
American gray wolf subspecies. The Mexican wolf is also considered the
rarest of the surviving (nonextinct) subspecies and has been accorded
the highest recovery priority by international wolf experts.
Releasing captive-raised Mexican wolves furthers the objective of
the Mexican Wolf Recovery Plan. The Plan, if fully implemented, will
result in the reestablishment of a wild population of at least 100
Mexican wolves. Also, release of wolves into the wild will reduce the
potential negative effects of keeping them in captivity in perpetuity.
If a reintroduction into the wild from the captive population does not
occur within a reasonable period of time, genetic, physical, or
behavioral changes resulting from prolonged captivity could render the
captive animals unsuited for reintroduction and devastate their
prospects for recovery.
Designation of the released wolves as nonessential experimental is
considered necessary to obtain needed State, tribal,
[[Page 19240]]
local, and private cooperation. This designation also allows for
management flexibility to mitigate negative impacts of Mexican wolf
recovery, such as livestock depredation. Without such flexibility
intentional illegal killing of wolves would likely harm the prospects
for successful recovery.
Potential for conflict with Federal and other activities: As
indicated, considerable management flexibility has been incorporated
into the proposed experimental population rule to reduce potential
conflicts between wolves and the activities of governmental agencies,
livestock operators, hunters, and others. No major conflicts with
current management of Federal, State, private, or tribal lands are
anticipated. Mexican wolves are expected to be able to tolerate most of
the current land uses in the designated wolf recovery areas. However,
temporary restrictions on human activities may be imposed around
release sites, active dens, and rendezvous sites. Limited backcountry
National Forest road closures may be necessary if illegal killings of
wolves occur; this would not affect the White Sands Wolf Recovery Area.
Also, the USDA's Animal Damage Control Division will discontinue use of
M-44's and choking-type snares in ``occupied Mexican wolf range'' (see
definition in proposed Section 17.84(j)(10)). Other predator control
activities may be restricted or modified pursuant to a cooperative
management agreement or a conference between the United States
Department of Agriculture's Animal Damage Control Division and the
Service.
The Service and other authorized agencies may harass, take, remove,
or translocate Mexican wolves under certain circumstances described in
detail in the proposed rule. Private citizens also are given broad
authority to harass Mexican wolves (for purposes of scaring them away
from livestock) and they may take (including to kill or injure) them
under narrow circumstances, that is, in cases of defense of human life
or when wolves are in the act of attacking their livestock (if certain
conditions are met). In addition, ranchers can seek compensation from a
privately-funded depredation compensation fund if depredation on their
livestock occurs.
The Service does not intend to change the proposed ``nonessential
experimental'' designation to ``essential experimental,''
``threatened'', or ``endangered'' and the Service does not intend to
designate critical habitat for the Mexican wolf. Critical habitat can
not be designated under the nonessential experimental classification,
16 U.S.C. 1539(j)(2)(C)(ii). The Service foresees no likely situation
which would result in such changes in the future. Nevertheless, to
ensure that such changes do not occur, the following condition exists
in the proposed rule, paragraph (j)(9)--if legal actions or lawsuits
compel a change in the population's legal status to essential
experimental, threatened, or endangered, or compel the designation of
critical habitat for wolves within the experimental population area,
then all reintroduced Mexican wolves will be removed from the wild and
the experimental population rule will be revoked.
Public Comments Solicited
The Service solicits comments or suggestions on the proposed
experimental population rule from the public, States, tribes, other
concerned governmental agencies, the scientific community, industry,
potentially affected landowners, or any other interested party.
Comments must be received within 60 days of publication of this
proposed rule in the Federal Register.
The Service will hold public hearings to obtain additional verbal
and written information. The location, dates, and times of these
hearings will be announced in a forthcoming issue of the Federal
Register, in newspapers, and in a mailing to those persons on the
Mexican Wolf Recovery Program mailing list.
Any final decision on this proposal will take into consideration
the comments and any additional information received by the Service.
These may lead to a final rule that differs from this proposal.
National Environmental Policy Act
A draft Environmental Impact Statement on the Service's proposal to
reintroduce the Mexican wolf in the southwestern United States has been
prepared and is available to the public (see ADDRESSES section). The
draft Environmental Impact Statement should be referred to for analysis
of the Proposed Action and alternatives to it; also, the draft
Environmental Impact Statement contains detailed references for the
background information provided here.
Required Determinations
This proposed rule has been reviewed by the Office of Management
and Budget under Executive Order 12866. The rule will not have
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601, et seq.). The final
rule will not significantly change costs to industry or governments.
Furthermore, the rule produces no adverse effects on competition,
employment, investment, productivity, innovation, or the ability of
United States enterprises to compete with foreign-based enterprises in
domestic or export markets.
This proposed rule has been reviewed under Executive Order 12630,
the Attorney General Guidelines, Department Guidelines, and the
Attorney General Supplemental Guidelines to determine the takings
implications of the proposed rule, if it were promulgated as currently
drafted. One issue of concern is the depredation of livestock by
reintroduced wolves. However, such depredation by a wild animal would
not be a ``taking'' under the 5th Amendment. One of the reasons for the
experimental nonessential designation is to allow the agency and
private entities flexibility in managing the wolves, including the
elimination of a wolf when there is a confirmed kill of livestock.
This proposed rule has been reviewed under Executive Order 12612 to
determine Federalism considerations in policy formulation and
implementation. Evidently, one or more counties in the vicinity of the
wolf reintroduction area have enacted ordinances specifically
prohibiting the introduction of the wolf (among other species) within
county boundaries. However, the United States Congress has given the
Secretary of the Interior explicit statutory authority, in section
10(j) of the Act, to promulgate this rule, and under the Supremacy
Clause of the United States Constitution, this has the effect of
preempting State regulation of wildlife to the extent in conflict with
this proposed rule. Nevertheless, the Service has endeavored to
cooperate with State wildlife agencies and county and tribal
governments in the preparation of this proposed rule.
Author
The primary author of this document is Mr. David R. Parsons (see
ADDRESSES section) at telephone 505/248-6920; or facsimile 505/248-
6922.
List of Subjects in 50 CFR Part 17
Endangered and threatened species, Exports, Imports, Reporting and
recordkeeping requirements, and Transportation.
Proposed Regulation Promulgation
Accordingly, the Service hereby proposes to amend part 17,
subchapter B of chapter I, title 50 of the Code of Federal Regulations,
as set forth below:
[[Page 19241]]
PART 17--[AMENDED]
1. The authority citation for part 17 continues to read as follows:
Authority: 16 U.S.C. 1361-1407; 16 U.S.C. 1531-1544; 16 U.S.C.
4201-4245; Pub. L. 99-625, 100 Stat. 3500, unless otherwise noted.
2. In Sec. 17.11(h), the table entry for ``Wolf, gray'' under
MAMMALS is revised to read as follows:
Sec. 17.11 Endangered and threatened wildlife.
* * * * *
(h) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Species Vertebrate
------------------------------------------------------ population where Critical Special
Historic range endangered or Status When listed habitat rules
Common name Scientific name threatened
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
Mammals
* * * * * * *
Wolf, gray...................... Canis lupus........ Holarctic......... U.S.A. (48 E 1. 6. 13. 35, 561, 17.95(a) NA
conterminous 562,______.
States. except MN
and where listed
as an
experimental
population)..
Do.............................. ......do........... ......do.......... U.S.A. (MN)....... T 35................. 17.95(a) 17.40(d)
Do.............................. ......do........... ......do.......... U.S.A. (WY and XN 561, 562........... NA
portions of ID 17.84(i)
and MT--see
17.84(i))..
Do.............................. ......do........... ......do.......... U.S.A. (specific XN NA................. 17.84(j).
portions of AZ
NM. and TX--see
17.84(j))..
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
3. Section 17.84 is amended by adding paragraph (j) to read as
follows:
Sec. 17.84 Special rules--vertebrates.
* * * * *
(j) Mexican gray wolf (Canis lupus baileyi).
(1) The Mexican gray wolf (Mexican wolf) subpopulations
reestablished in the Blue Range Wolf Recovery Area and in the White
Sands Wolf Recovery Area within the Mexican Wolf Experimental
Population Area, identified in paragraph (j)(6) of this section, are
one nonessential experimental population. This nonessential
experimental population will be managed in accordance with these
provisions.
(2) The Fish and Wildlife Service (Service) finds that
reintroduction of an experimental population of Mexican wolves into the
subspecies' probable historic range will further the conservation of
the Mexican wolf subspecies and of the gray wolf species. The Service
also finds that the experimental population is not ``essential,'' under
50 CFR 17.81(c)(2).
(3) You must not take any wolf in the wild within the Mexican Wolf
Experimental Population Area except as provided in this rule. The
Service may refer take of a wolf contrary to this rule to the
appropriate authorities for prosecution.
(i) Throughout the entire Mexican Wolf Experimental Population
Area, you will not be in violation of the Endangered Species Act (Act)
for unavoidable and unintentional take (including killing or injuring)
of a wolf, when such take is non-negligent and incidental to a legal
activity, such as hunting, trapping, driving, or recreational
activities, and you report the take promptly (within 24 hours) to the
Service's Mexican Wolf Recovery Coordinator or to a Service appointed
agency representative.
(ii) Also throughout the entire Mexican Wolf Experimental
Population Area, excluding areas within the national park system and
national wildlife refuge system, no Federal agency or their contractors
will be in violation of the Act for take of a wolf resulting from any
authorized agency action. This provision does not exempt agencies and
their contractors from complying with section 7(a)(4) of the Act which
requires a conference with the Service if they propose an action that
is likely to jeopardize the continued existence of the Mexican wolf.
(iii) No land use restrictions will be imposed on private or tribal
reservation lands for Mexican wolf recovery without the concurrence of
the private owner or tribal government. On public lands, public and
tribal agencies may temporarily restrict human access and disturbance-
causing land use activities, such as timber harvesting and mining,
within a 1-mile radius around release pens when wolves are in them,
around active dens between March 1 and June 30, and around active wolf
rendezvous sites between June 1 and September 30, as necessary. If
documented illegal killing of a wolf occurs the United States Forest
Service may, in consultation with the Service, close back-country roads
on National Forest lands (except thoroughfares) for as long as
necessary to protect the wolves.
(iv) In areas within the national park system and national wildlife
refuge system, Federal agencies must treat Mexican wolves as a
threatened species for purposes of complying with section 7 of the Act.
(v) On public lands leased for grazing anywhere within the Mexican
Wolf Experimental Population Area, including within the designated wolf
recovery areas, when and where livestock are legally present, livestock
owners or their agents:
(A) May harass wolves, for purposes of scaring them away, in the
general vicinity (within 500 yards) of livestock (i.e., cattle, sheep,
horses, mules, and burros or as defined in State and tribal wolf
management plans as approved by us) in an opportunistic, noninjurious
manner (no temporary or permanent physical damage may result) at any
[[Page 19242]]
time; provided that wolves cannot be purposely attracted, tracked,
waited for, or searched out and then harassed; and provided that such
harassment is reported to the Service's Mexican Wolf Recovery
Coordinator or to a Service appointed agency representative within 7
days; and,
(B) May receive a written permit under the Act from the Service or
an agency designated by the Service, valid for up to 45 days, to take
(including kill or injure) a specific number of wolves actually engaged
in the act of killing, wounding, or biting livestock; provided that,
prior to the issuance of such a permit, six or more breeding Mexican
wolf pairs occur in the Blue Range Wolf Recovery Area, or three or more
breeding Mexican wolf pairs occur in the White Sands Wolf Recovery
Area; and provided that an authorized agent of the Service, the United
States Department of Agriculture's (USDA) Animal Damage Control
Division, or the State has documented previous livestock loss or injury
caused by wolves and agency efforts to resolve the problem are
completed. Livestock owners or their agents must report take of wolves
under such a permit to the Service's Mexican Wolf Recovery Coordinator
or to a Service appointed agency representative within 24 hours. There
must be evidence of freshly wounded or killed livestock by wolves.
(vi) On private or tribal land anywhere within the Mexican Wolf
Experimental Population Area, property owners, livestock owners,
tenants, or their designated agents:
(A) may harass wolves in the immediate vicinity (within 500 yards)
of people, buildings, facilities, pets, livestock, or other domestic
animals in an opportunistic, noninjurious manner (no temporary or
permanent physical damage may result) at any time; provided that wolves
cannot be purposely attracted, tracked, or searched out and then
harassed; and provided that such harassment is reported to the
Service's Mexican Wolf Recovery Coordinator or to a Service appointed
agency representative within 7 days; and,
(B) may take (including kill or injure) any wolf actually engaged
in the act of killing, wounding, or biting livestock; provided that
livestock freshly (less than 24 hours) wounded (torn flesh and
bleeding) or killed by wolves is present; and further provided that the
take is reported to the Service's Mexican Wolf Recovery Coordinator or
a Service appointed agency representative within 24 hours.
(vii) Authorized Service, USDA Animal Damage Control Division,
tribe, and State employees may capture and/or translocate any Mexican
wolf in the nonessential experimental population consistent with the
Service's approved management plan or special management measure. Such
plan or measure may include capture and/or translocation of wolves that
prey on livestock, attack pets or domestic animals other than livestock
on private land, impact game populations in ways which may inhibit
further wolf recovery, prey on members of the desert bighorn sheep herd
found on the White Sands Missile Range and San Andres National Wildlife
Refuge, so long as the State of New Mexico lists it as a species to be
protected, are considered problem wolves, are a nuisance, or are
conflicting with a major land use, or are necessary for research.
Authorized Federal, State, or tribal personnel may also carry out wolf
capture and/or translocation for other purposes the Service has
authorized, such as genetic management, and may use lethal methods of
take when reasonable attempts to capture wolves alive fail and the
Service determines that removal of a particular wolf or wolves from the
wild is necessary. Authorized Federal, State, or tribal personnel may
carry out any management measure that is a part of a Service approved
management plan. Also, the USDA Animal Damage Control Division will
discontinue use of M-44's and choking-type snares in ``occupied Mexican
wolf range'' (see definition in proposed section 17.84(j)(10)). The
Service may restrict or modify other predator control activities
pursuant to a cooperative management agreement or a conference between
us and the USDA's Animal Damage Control Division.
(viii) You may harass or take a Mexican wolf in self defense or
defense of others, provided that you promptly report the harassment or
take to the Service's Mexican Wolf Recovery Coordinator or to a Service
appointed agency representative. If the Service or an agency authorized
through a cooperative management plan determine that a wolf presents a
threat to human life or safety, the Service or the authorized agency
may place it in captivity or euthanize it.
(ix) Intentional taking of any wolf in the Mexican Wolf
Experimental Population Area, except as described above, is prohibited.
The Service encourages individuals authorized to take wolves to use
nonlethal means. You must immediately (within 24 hours) deliver all
wolves (live or dead), pelts, or parts taken to the Service's Mexican
Wolf Recovery Coordinator or to a Service appointed agency
representative.
(4) You may not possess, sell, deliver, carry, transport, ship,
import, or export by any means whatsoever, any wolf or wolf part from
the experimental population taken or possessed in violation of these
regulations or in violation of applicable State or tribal fish and
wildlife laws or regulations or the Act.
(5) You may not attempt to commit, solicit another to commit, or
cause to be committed, any offense defined in this section.
(6) The two designated recovery areas for Mexican wolves classified
as nonessential experimental that lie within the subspecies' probable
historic range are:
(i) The White Sands Wolf Recovery Area in south-central New Mexico,
including all of the White Sands Missile Range, the White Sands
National Monument, and the San Andres National Wildlife Refuge, and the
area adjacent and to the west of the Missile Range bounded on the south
by the southerly boundary of the USDA Jornada Experimental Range and
the northern boundary of the New Mexico State University Animal Science
Ranch; on the west by the New Mexico Principal Meridian; on the north
by the Pedro Armendaris Grant boundary and the Sierra-Socorro County
line; and on the east by the western boundary of the Missile Range
(Figure 1). Actual releases of captive-raised wolves will take place,
generally as described in our draft Environmental Impact Statement on
Mexican wolf reintroduction, within the White Sands Wolf Recovery Area
primary recovery zone. This is the area within the White Sands Missile
Range bounded on the north by the road from the former Cain Ranch
Headquarters to Range Road 16, Range Road 16 to its intersection with
Range Road 13, Range Road 13 to its intersection with Range Road 7; on
the east by Range Road 7; on the south by Highway 70; and on the west
by the Missile Range boundary. The Service will allow the wolf
subpopulation to expand into the White Sands Wolf Recovery Area
secondary recovery zone, which is the remainder of the White Sands Wolf
Recovery Area not in the primary recovery zone.
(ii) The Blue Range Wolf Recovery Area, including all of the Apache
National Forest and all of the Gila National Forest in east-central
Arizona and west-central New Mexico (Figure 2). Actual releases of
captive-raised Mexican wolves will take place, generally as described
in our draft Environmental Impact Statement on Mexican wolf
reintroduction, within the Blue Range Wolf Recovery Area primary
recovery zone. This is the area within
[[Page 19243]]
the Apache National Forest bounded on the north by the Apache-Greenlee
County line; on the east by the Arizona-New Mexico State line; on the
south by the San Francisco River (eastern half) and the southern
boundary of the Apache National Forest (western half); and on the west
by the Greenlee-Graham County line (San Carlos Apache Reservation
boundary). The Service will allow the wolf subpopulation to expand into
the Blue Range Wolf Recovery Area secondary recovery zone, which is the
remainder of the Blue Range Wolf Recovery Area not in the primary
recovery zone.
(iii) The boundaries of the Mexican Wolf Experimental Population
Area are the portion of Arizona lying north of Interstate Highway 10
and south of Interstate Highway 40; the portion of New Mexico lying
north of Interstate Highway 10 in the west, north of the New Mexico-
Texas boundary in the east, and south of Interstate Highway 40; and the
portion of Texas lying north of United States Highway 62/180 and south
of the Texas-New Mexico boundary (Figure 3). The Service is not
proposing wolf recovery throughout this area, only within the White
Sands and Blue Range Wolf Recovery Areas described in paragraph
(j)(6)(i) and (j)(6)(ii) of this subsection. The purpose of the larger
experimental population area designation is to distinguish the legal
status of any wolf found there. After the first captive wolf release,
wolves found in the wild in the Mexican Wolf Experimental Population
Area will be subject to management under this rule. If a wolf is
captured inside the Mexican Wolf Experimental Population Area after the
first release but outside the designated wolf recovery areas, it will
be returned and re-released or put into the captive breeding program.
If a wolf is found in the United States outside the boundaries of the
Mexican Wolf Experimental Population Area (and not within any other
wolf experimental population area) the Service will presume it to be of
wild origin with full endangered status (or threatened in Minnesota)
under the Act, unless evidence, such as a radio-collar or
identification mark, establishes otherwise. If such evidence exists,
the Service or an authorized agency will attempt to promptly capture
the wolf and return and re-release it or put into the captive breeding
program. Such a wolf is otherwise not subject to this rule outside the
designated Mexican Wolf Experimental Population Area.
(7) If Mexican wolves of the experimental population occur on
public lands outside the designated wolf recovery areas, but within the
Mexican Wolf Experimental Population Area, the Service or an authorized
agency will attempt to recapture any radio-collared lone wolf and any
lone wolf or member of an established pack causing livestock
depredations. The agencies will not routinely recapture and return pack
members that make occasional forays onto public land outside the
designated wolf recovery areas and uncollared lone wolves on public
land. However, the Service will capture and return to a recovery area
or to captivity packs from the nonessential experimental population
that establish territories on public land outside the designated wolf
recovery areas. If any wolves move onto private or tribal lands outside
the designated recovery areas, but within the Mexican Wolf Experimental
Population Area, the Service or an authorized agency will develop
management actions in cooperation with the land owner including
recapture if requested by the land owner or tribal government.
(8) The Service will continuously evaluate Mexican wolf
reintroduction progress and prepare periodic progress reports, detailed
annual reports, and full evaluations after 3 and 5 years that recommend
continuation or termination of the reintroduction effort.
(9) The Service does not intend to change the ``nonessential
experimental'' designation to ``essential experimental,''
``threatened,'' or ``endangered'' and does not intend to designate
critical habitat for the Mexican wolf. Critical habitat cannot be
designated under the nonessential experimental classification. 16
U.S.C. 1539(j)(2)(C)(ii). The Service foresees no likely situation
which would result in such changes. The Service would remove from the
wild all reintroduced Mexican wolves designated as nonessential
experimental and revoke the experimental status and regulations if
legal actions or lawsuits compel a change in the population's legal
status to essential experimental, threatened, or endangered or compel
the designation of critical habitat within the Mexican Wolf
Experimental Population Area, or if within 90 days of the initial
release date, the Service discovers a naturally occurring population of
wild wolves, consisting of at least two breeding pairs that for 2
consecutive years have each successfully raised two offspring, existing
within the White Sands Wolf Recovery Area or Blue Range Wolf Recovery
Area boundaries. The Service would manage and protect any such
naturally occurring wolves as endangered species under the Act.
(10) Definitions--Key terms used in the rule have the following
definitions.
Breeding pair. An adult male and an adult female wolf that have
produced at least two pups that survived until December 31 of the year
of their birth, during the previous breeding season.
Depredation. The confirmed killing or maiming of lawfully present
domestic livestock on Federal, State, tribal, or other public lands, or
private lands by one or more wolves. The Service, USDA Animal Damage
Control, or Service-authorized State or tribal agencies will confirm
killing or maiming of domestic livestock.
Engaged in the act of killing, wounding, or biting livestock. To be
engaged in the pursuit and grasping, biting, attacking, wounding, or
feeding upon livestock that are alive. If wolves are observed feeding
on livestock carcasses, you cannot assume that wolves killed the
livestock until proper authorities investigate and confirm that wolves
were responsible for that or other livestock losses in the immediate
area (1-mile radius).
Harass. Harass is defined as ``intentional or negligent act or
omission which creates the likelihood of injury to the wildlife by
annoying it to such an extent as to significantly disrupt normal
behavioral patterns which include, but are not limited to breeding,
feeding, or sheltering'' (50 CFR 17.3). For the purposes of this
proposed experimental population rule the Service permits only
``opportunistic,'' noninjurious harassment (see definition below) and
limits it to approaching wolves on foot, horseback, or nonmotorized or
motorized vehicle (no closer than 20 feet); discharging firearms or
other projectile launching devices in proximity to but not in the
direction of wolves; throwing objects in the general direction of but
not at wolves; or making any loud noise in proximity to wolves. The
basic intent is to scare or chase wolves from the immediate area
without causing physical injuries.
Impact on game populations in ways which may inhibit further wolf
recovery. The Service encourages States and tribes to describe
unacceptable impacts on game populations in their management plans
subject to our approval. Until such time the term will mean the
following: Two consecutive years with a cumulative 35 percent decrease
in population or hunter harvest estimates for a particular species of
ungulate in a game management unit or distinct herd segment compared to
the prewolf 5-year average (unit or herd must contain average of
greater than 100 animals). If wolf predation is shown to be a primary
cause of ungulate population declines (greater than 50 percent of
documented adult or young mortality), then wolves
[[Page 19244]]
may be moved to reduce ungulate mortality rates and assist in herd
recovery, but only in conjunction with application of other common,
professionally acceptable, wildlife management techniques.
Occupied Mexican wolf range. (1) Area of confirmed presence of
resident breeding packs or pairs of wolves or area consistently used by
at least one resident wolf over a period of at least one month. The
Service must confirm or corroborate wolf presence. Exact delineation of
the area will be described by:
(i) Five-mile radius around all locations of wolves and wolf sign
confirmed as described above (nonradio-monitored);
(ii) 5-mile radius around radio locations of resident wolves when
fewer than 20 radio locations are available (for radio-monitored wolves
only); or
(iii) 3-mile radius around the convex polygon developed from more
than 20 radio locations of a pack, pair, or single wolf taken over a
period of at least 6 months (for radio-monitored wolves).
(2) This definition applies only within the Mexican Wolf
Experimental Population Area.
Opportunistic, noninjurious harassment (see ``harass''). This is
the only type of harassment the Service permits under the experimental
population rule. Opportunistic means as the wolf presents itself (i.e.,
the wolf travels onto and is observed on private land or near
livestock). You cannot track a wolf and then harass it or harass it by
aircraft. You cannot chase and harass a wolf for an extended period of
time (over 15 minutes). Any harassment must not cause bodily injury,
maiming, or death.
Population of naturally occurring wild wolves. At least two
breeding pairs of wolves successfully raising at least two young each
year (until December 31 of the year of their birth), for 2 consecutive
years in the Mexican Wolf Experimental Population Area.
Primary recovery zone. An area where the Service proposes to
release Mexican wolves, and where the Service may return and re-release
them if necessary, and where managers will actively support recovery of
the reintroduced population.
Problem wolves. Wolves that have depredated on lawfully present
domestic livestock or wolves from a group or pack including adults,
yearlings, and young-of-the-year that were directly involved in the
depredations; or fed upon the livestock remains that were a result of
the depredation; or were fed by or are dependent upon adults involved
with the depredations (because before these young animals mature to
where they can survive on their own, they will travel with the pack and
learn the pack's depredation habits). Wolves that have depredated on
domestic animals other than livestock, two times in an area within 1
year. Wolves that are habituated to humans, human residences, or other
facilities.
Secondary recovery zone. An area adjacent to a primary recovery
zone which the Service does not propose for Mexican wolf releases, but
in which the Service allows released wolves to disperse, and where
managers will actively support recovery of the reintroduced population.
Take. The Act defines ``take'' as--``to harass, harm, pursue, hunt,
shoot, wound, kill, trap, capture, or collect, or to attempt to engage
in any such conduct'' (16 U.S.C. 1532(19)). See above definition of
Harass which includes definition of permitted harassment, and see
definition of Unavoidable and unintentional take below.
Unavoidable and unintentional take. Accidental, non-negligent take
(see above definition of ``Take'') which occurs despite reasonable
care, is incidental to an otherwise lawful activity and without the
purpose to do so. Examples would include striking a wolf with an
automobile or capturing a wolf in a trap set obviously for another
species. Note--Shooting a wolf when the individual states he or she
believed it to be an animal other than a wolf does not qualify as
unavoidable or unintentional take. Shooters have the responsibility to
be sure of their targets.
Wolf recovery area. A designated area where managers will actively
support reestablishment of Mexican wolf populations.
Figures to Sec. 17.84(j)
BILLING CODE 4310-55-P
[[Page 19245]]
[GRAPHIC] [TIFF OMITTED] TP01MY96.001
[[Page 19246]]
[GRAPHIC] [TIFF OMITTED] TP01MY96.002
[[Page 19247]]
[GRAPHIC] [TIFF OMITTED] TP01MY96.003
[[Page 19248]]
BILLING CODE 4310-55-C
Dated: December 20, 1995.
George T. Frampton, Jr.,
Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 96-10665 Filed 4-30-96; 8:45 am]
BILLING CODE 4310-55-P
Complete official Federal Register PDF
FR Doc. 96-10660 Special Local Regulations; Suncoast Kilo Run; Suncoast Offshore Challenge; Suncoast Offshore Grand Prix; Sarasota, FL
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19220-19222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10660]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Coast Guard
33 CFR Part 100
[CGD07-96-008]
RIN 2115-AE46
Special Local Regulations; Suncoast Kilo Run; Suncoast Offshore
Challenge; Suncoast Offshore Grand Prix; Sarasota, FL
AGENCY: Coast Guard, DOT.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard proposes to establish special local
regulations for Suncoast Kilo Run, Suncoast Offshore Challenge and
Suncoast Offshore Grand Prix, all events sponsored by the S.O.R.A.
(Suncoast Racing Association). The Suncoast Kilo Run event would be
held annually at 8 a.m. to 1 p.m. EDT (Eastern Daylight Time), on the
first Friday of July. The Suncoast Offshore Challenge and Suncoast
Offshore Grand Prix events would be held annually at 11 a.m. to 4 p.m.
EDT, on the first Saturday and Sunday of July. These proposed
regulations are intended to promote safe navigation on the waters in
the Gulf of Mexico in the vicinity of Sarasota and on the waters in
North Sarasota Bay, Florida, by controlling the traffic entering,
exiting, and traveling within these waters. These proposed regulations
are necessary to provide for the safety of life on navigable waters
during the event.
DATES: Comments must be received on or before May 31, 1996.
ADDRESSES: Comments may be mailed to U.S. Coast Guard Group St.
Petersburg, 600 8th Ave. S.E., St. Petersburg, Florida 33701-5099, or
may be delivered to operations office at the same address between 8
a.m. and 4 p.m. EDT, Monday through Friday, except federal holidays.
The telephone number is (813) 824-
[[Page 19221]]
7533. Comments will become a part of the public docket and will be
available for copying and inspection at the same address.
FOR FURTHER INFORMATION CONTACT: LTJG J.W. Nelson, project officer,
U.S. Coast Guard Group St. Petersburg, FL at (813) 824-7533.
SUPPLEMENTARY INFORMATION:
Request for Comments
The Coast Guard encourages interested persons to participate in
this rulemaking by submitting written views, data, or arguments.
Persons submitting comments should include their names, addresses,
identify the notice (CGD07-96-008) and the specific section of this
proposal to which their comments apply, and give reasons for each
comment. The Coast Guard will consider all comments received during the
comment period. The regulations may be changed in view of the comments
received. All comments received before the expiration of the comment
period will be considered before final action is taken on this
proposal.
No public hearing is planned, but one may be held if written
requests for a hearing are received, and it is determined that the
opportunity to make oral presentations will add to the rulemaking
process.
Discussion of Proposed Regulations
The proposed regulations are needed to provide for the safety of
life during the Suncoast Kilo Run, Suncoast Offshore Challenge and
Suncoast Offshore Grand Prix, all sponsored by the S.O.R.A. (Suncoast
Racing Association). These Proposed regulations are intended to promote
safe navigation on the waters in North Sarasota Bay and on the Gulf of
Mexico in the vicinity of Sarasota, Florida, by controlling the traffic
entering, exiting, and traveling within these waters. Historically
during these races, there have been between 150 and 300 participant ant
spectator craft. There would be approximately between 50 and 100 power
boats, 21 to 50 feet in length, participating in these races at high
speeds. The anticipated concentration of spectator and participant
vessels associated with the Suncoast Kilo Run, Suncoast Offshore
Challenge and Suncoast Offshore Grand Prix poses a safety concern,
which is addressed in these special local regulations. The Suncoast
Kilo Run event would be held annually at 8 a.m. to 1 p.m. EDT, on the
first Friday of July. The Suncoast Offshore Challenge and Suncoast
Offshore Grand Prix events would be held annually at 11 a.m. to 4 p.m.
EDT, on the first Saturday and Sunday of July.
These proposed special local regulations for the Suncoast Kilo Run
would establish a ``no wake'' zone in an area between markers #13
(27 deg.20.82N, 82 deg.33.78W, LLNR 48035) and #17 (27 deg.24.5N,
82 deg.36.8W, LLNR 48190) in North Sarasota Bay. All coordinates
referenced are datum: NAD 83. Spectator craft would be permitted in the
area but would be required to stay clear of the designated race lanes.
This race would be held annually on the First Friday of July, between 8
a.m. and 1 p.m. EDT.
The proposed special local regulations for the Suncoast Offshore
Challenge would not permit anchoring seaward of the shoreside legs of
the racecourse out to three nautical miles from shore, from 10 a.m. to
4 p.m. EDT. Spectator craft would be permitted near the race area but
would be required to stay clear of the race lanes. Anchoring for
spectators would be permitted shoreward of the shoreside legs of the
racecourse. All vessel traffic exiting New Pass between 11 a.m. to 4
p.m. EDT would exit the marked channel at New Pass Channel daybeacon #3
(27 deg.26.46' N, 82 deg.41.7' W, LLNR 18100), and 4 (27 deg.26.4' N,
82 deg.41.68' W, LLNR 18105), and would proceed in a northerly
direction shoreward of the spectator craft until well clear of the race
course. All coordinates referenced use datum: NAD 1983. Big Sarasota
Pass would be closed to all inbound and outbound vessel traffic, other
than spectator craft, from 10 a.m. to 4 p.m. EDT, annually during the
first Saturday of July.
The proposed special regulations for the Suncoast Offshore Grand
Prix would not permit anchoring seaward of the shoreside legs of the
racecourse out to three nautical miles from shore, from 10 a.m. to 4
p.m. EDT, annually on the first Sunday of July. Spectator craft would
be permitted near the race area but would by required to stay clear of
the race lanes. Anchoring for spectators would be permitted shoreward
of the shoreside legs of the racecourse. All vessel traffic not
involved with the Suncoast Offshore Grand Prix exiting New Pass between
10 a.m. and 4 p.m EDT would exit the marked channel at New Pass Channel
daybeacon #3 (27 deg.26.46' N, 82 deg.41.7' W, LLNR 18100) and #4
(27 deg.26.4' N, 82 deg.41.68' W, LLNR 18105), and would proceed in a
northerly direction shoreward of the spectator craft, taking action to
avoid a close-quarters situation with the spectator craft until finally
past and clear of the racecourse. All coordinates referenced use datum:
NAD 1983. Big Sarasota Pass would be closed to all inbound and outbound
vessel traffic, other than spectator craft, from 10 a.m. and 4 p.m.
EDT, annually on the first Sunday of July.
Regulatory Evaluation
This proposal is not a significant regulatory action under section
3(f) of Executive Order 12866 and does not require an assessment of
potential costs and benefits under section 6(a)(3) of that order. It
has been exempted from review by the Office of Management and Budget
under that order. It is not significant under the regulatory policies
and procedures of the Department of Transportation (DOT) (44 FR 11040;
February 26, 1979). The Coast Guard expects the economic impact of this
rule to be so minimal that a full Regulatory Evaluation under paragraph
10e of the regulatory policies and procedures of DOT is unnecessary.
The proposed regulation would last for only 5 hours on each day of the
event.
Small Entities
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Coast Guard must consider whether this proposal will have a significant
economic impact on a substantial number of small entities. ``Small
entities'' include independently owned and operated small businesses
that are not dominant in their field and that otherwise qualify as
``small business concerns'' under Section 3 of the Small Business Act
(15 U.S.C. 632).
For reasons set forth in the above Regulatory Evaluation, the Coast
Guard certifies under 5 U.S.C. 605(b) that this proposal, if adopted,
will not have a significant economic impact on a substantial number of
small entities.
Collection of Information
These proposed regulations contain no collection of information
requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et
seq.).
Federalism
This action has been analyzed in accordance with the principals and
criteria contained in Executive Order 12612, and it has been determined
that the rulemaking does not have sufficient Federalism implications to
warrant the preparation of a Federalism Assessment.
Environmental Assessment
The Coast Guard has considered the environmental impact of this
proposal and has concluded that preparation of an environmental Impact
Statement is not necessary. An environmental assessment and a finding
of no
[[Page 19222]]
significant impact have been prepared and are available in the docket
for inspection or copying where indicated under ADDRESSES. The Coast
Guard has concluded that this proposed action would not significantly
affect the quality of the human environment.
List of Subjects in 33 CFR Part 100
Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.
Proposed Regulations
In consideration of the foregoing, the Coast Guard is proposing to
amend Part 100 of Title 33, Code of Federal Regulations, as follows:
PART 100--[AMENDED]
1. The authority citation for Part 100 continues to read as
follows:
Authority: 33 U.S.C. 1233; 49 CFR 1.46 and 33 CFR 100.35.
2. A new section Sec. 100.718 is added to read as follows:
Sec. 100.718 Annual Suncoast Kilo Run; Sarasota Bay, Sarasota, FL.
(a) Regulated area. The regulated area is established in Sarasota
Bay with the northwest corner pint at Whale Key, position
27 deg.23'53'' N, 82 deg.37'46'' W, extending to the northeast corner
point at Bayshore Gardens Channel, position 27 deg.25'11'' N,
82 deg.35'45'' W, then extending to the southeast corner point at
Whitaker Bayou, position 27 deg.21'22'' N, 82 deg.33'14'' W, and then
to the southwest corner point at Quick Point, position 27 deg.20'18''
N, 82 deg.34'' W. All coordinates referenced use datum: NAD 83.
(b) Special local regulations. (1) In accordance with these
regulations, the regulated area is designated as a ``no wake'' zone.
Spectator craft are permitted into the area, but are prohibited from
entering the race course areas described in (b)(2) of this section.
(2) Inside the ``no wake'' zone are two designated areas
surrounding the primary and alternate race courses. Primary course
``A'' is bounded by a line connecting the northeast corner point at
position 27 deg.22'10'' N, 82 deg.36'09'' W, a southeast corner point
at position 27 deg.21'31'' N, 82 deg.35'37'' W, a southwest corner
point at position 27 deg.21'27'' N, 82 deg.35'48'' W, and a northwest
corner point at position 27 deg.22'05'' N, 82 deg.36'16'' W. Alternate
course ``B'' is bounded by a line connecting the northeast corner point
at position 27 deg.23'11'' N, 82 deg.34'31'' W, a southeast corner
point at position 27 deg.22'35'' N, 82 deg.34'03'' W, a southwest
corner point at position 27 deg.22'31'' N, 82 deg.34'08'' W, and
northwest corner point at position 27 deg.23'09'' N, 82 deg.34'38'' W.
All coordinates referenced use datum: NAD 83.
(3) Entry into the regulated area shall be in accordance with this
section.
(c) Effective date. This section is effective at 8 a.m. and
terminates at 1 p.m. EDT, annually during the first Friday of July.
2. A new section Sec. 100.719 is added to read as follows:
Sec. 100.719 Annual Suncoast Offshore Challenge; Gulf of Mexico,
Sarasota, FL.
(a) Regulated area. The regulated area is established by a line
drawn from the start/finish position 27 deg.19.15' N, 82 deg.35.90' W,
thence to position 27 deg.18.81' N, 82 deg.34.90' W, thence to position
27 deg.18.21' N, 82 deg.34.48' W, thence to position 27 deg.16.43' N,
82 deg.34.99' W, thence to position 27 deg.15.70' N, 82 deg.34.29' W,
thence to position 27 deg.15.86' N, 82 deg.33.44' W, thence to position
27 deg.14.73' N, 82 deg.32.37' W, thence to position 27 deg.14.62' N,
82 deg.32.54' W, thence to position 27 deg.14.93' N, 82 deg.35.25' W,
thence to position 27 deg.20.03' N, 82 deg.37.38' W, thence to position
27 deg.20.32' N, 82 deg.37.16' W, thence back to the start/finish
position. All coordinates referenced use datum: NAD 1983.
(b) Special local regulations. (1) No anchoring will be permitted
seaward of the shoreside boundaries of the regulated area out to three
nautical miles from shore, from 10 a.m. to 4 p.m. EDT, annually on the
first Saturday of July.
(2) Anchoring for spectators will be permitted shoreward of the
shoreside boundaries of the regulated area.
(3) All vessel traffic, not involved with the Suncoast Offshore
Challenge, exiting New Pass between 11 a.m. and 4 p.m. EDT will exit at
New Pass Channel daybeacon #3 (27 deg.26.46' N, 82 deg.41.7' W, LLNR
18100) and #4 (27 deg.26.4' N, 82 deg.41.68' W, LLNR 18105), and shall
proceed in a northerly direction shoreward of spectator craft taking
action to avoid a close-quarters situation until finally past and clear
of the racecourse. All coordinates referenced use datum: NAD 1983.
(4) Big Sarasota Pass will be closed to all inbound and outbound
vessel traffic, other than spectator craft, from 10 a.m. to 4 p.m. EDT.
(5) Entry into the regulated area shall be in accordance with this
regulation. Spectator vessels will stay clear of race area at all
times.
(c) Effective date. This section is effective at 10 a.m. and
terminates at 4 p.m. EDT, annually during the first Saturday of July.
2. A new section Sec. 100.720 is added to read as follows:
Sec. 100.720 Annual Suncoast Offshore Grand Prix; Gulf of Mexico,
Sarasota, FL.
(a) Regulated area. The regulated area is established by a line
drawn from the start/finish position 27 deg.19.15' N, 82 deg.35.90' W,
thence to position 27 deg.18.81' N, 82 deg.34.90' W, thence to position
27 deg.18.81' N, 82 deg.34.48' W, thence to position 27 deg.16.43' N,
82 deg.34.99' W, thence to position 27 deg.15.70' N, 82 deg.34.29' W,
thence to position 27 deg.15.86' N, 82 deg.33.44' W, thence to position
27 deg.14.73' N, 82 deg.32.37' W, thence to position 27 deg.14.62' N,
82 deg.32.54' W, thence to position 27 deg.14.93' N, 82 deg.35.25' W,
thence to position 27 deg.20.03' N, 82 deg.37.38' W, thence to position
27 deg.20.32' N, 82 deg.37.16' W, thence back to the start/finish
position. All coordinates referenced use datum: NAD 1983.
(b) Special local regulations. (1) No anchoring will be permitted
seaward of the shoreside boundaries of the regulated area out to three
nautical miles from shore, form 10 a.m. to 4 p.m. EDT.
(2) Anchoring for spectators will be permitted shoreward of the
shoreside boundaries of the regulated area.
(3) All vessel traffic not involved with the Suncoast Offshore
Grand Prix, exiting New Pass between 10 a.m. and 4 p.m. EDT will exit
at New Pass Channel daybeacon #3 (27 deg.26.46' N, 82 deg.41.7' W, LLNR
18100) and #4 (27 deg.26.4' N, 82 deg.41.68' W, LLNR 18105), and shall
proceed in a northerly direction shoreward of spectator craft taking
action to avoid a close-quarters situation until finally past and clear
of the racecourse. All coordinates referenced use datum: NAD 83.
(4) Big Sarasota Pass will be closed to all inbound and outbound
vessel traffic, other than spectator craft, from 10 a.m. to 4 p.m. EDT.
(5) Entry into the regulated area shall be in accordance with this
regulation. Spectator craft will stay clear of race area at all times.
(c) Effective date. This section is effective at 10 a.m. and
terminates at 4 p.m. EDT, annually during the first Sunday of July.
Dated: April 23, 1996.
Roger T. Rufe, Jr.,
Commander, Seventh Coast Guard District.
[FR Doc. 96-10660 Filed 4-30-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-10587 Standards For Business Practices Of Interstate Natural Gas Pipelines
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19211-19220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10587]
=======================================================================
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DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
18 CFR Parts 161, 250 and 284
[Docket No. RM96-1-000]
Standards For Business Practices Of Interstate Natural Gas
Pipelines
April 24, 1996.
AGENCY: Federal Energy Regulatory Commission, Energy.
ACTION: Notice of Proposed Rulemaking and Request for Office of
Management and Budget Emergency Processing of Submission of Collection
of Information.
-----------------------------------------------------------------------
SUMMARY: The Federal Energy Regulatory Commission is issuing a notice
of proposed rulemaking to revise the Commission's regulations to
require interstate natural gas pipelines to follow standardized
procedures for critical business practices--nominations; allocations,
balancing, and measurement; invoicing; and capacity release--and
standardized mechanisms for electronic communication between the
pipelines and those with whom they do business. The proposed
regulations incorporate by reference the proposed standards submitted
by the Gas Industry Standards Board (GISB) in response to the
Commission's October 25, 1995 Advanced Notice of Proposed Rulemaking
(ANOPR). 60 FR 55504 (Nov. 1, 1995).
GISB and others in the natural gas industry have requested
expedited processing of this proposed rule. Accordingly, pursuant to 5
CFR 1320.13, the Commission is providing notice of its request to the
Office of Management and Budget (OMB) for emergency processing of this
proposed collection of information by May 24, 1996.
DATES: Comments on the proposed rule are due May 24, 1996. Comments
should be filed with the Office of the Secretary and should refer to
Docket No. RM96-1-000.
Because the Commission has requested OMB to process the proposed
collection of information on an emergency basis, comments on the
proposed collection of information should be filed with OMB, attention
Desk Officer FERC, as soon as possible.
ADDRESSES:
Federal Energy Regulatory Commission, 888 First Street, NE., Washington
DC, 20426
Office of Management and Budget, Room 3019 NEOB, Washington, D.C.
20503, or via the Internet at [email protected].
FOR FURTHER INFORMATION CONTACT:
Michael Goldenberg, Office of the General Counsel, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC
20426,(202) 208-2294
Marvin Rosenberg, Office of Economic Policy, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426. (202) 208-1283
SUPPLEMENTARY INFORMATION: In addition to publishing the full text of
this document in the Federal Register, the Commission provides all
interested persons an opportunity to inspect or copy the contents of
this document during normal business hours in Room 2A, 888 First
Street, N.E., Washington D.C. 20426.
The Commission Issuance Posting System (CIPS), an electronic
bulletin
[[Page 19212]]
board service, provides access to the texts of formal documents issued
by the Commission. CIPS is available at no charge to the user and may
be accessed using a personal computer with a modem by dialing 202-208-
1397 or 1-800-856-3920. To access CIPS, set your communications
software to use 19200, 14400, 12000, 9600, 7200, 4800, 2400, 1200, or
300 bps, full duplex, no parity, 8 data bits, and 1 stop bit. The full
text of this document will be available on CIPS in ASCII and
WordPerfect 5.1 format. The complete text on diskette in WordPerfect
format may also be purchased from the Commission's copy contractor, La
Dorn Systems Corporation, also located in Room 2A, 888 First Street,
N.E., Washington D.C. 20426.
The Commission's bulletin board system also can be accessed through
the FedWorld system directly by modem or through the Internet. To
access the FedWorld system by modem:
Dial (703) 321-3339 and logon to the FedWorld system.
After logging on, type: /go FERC
To access the FedWorld system, through the Internet:
Telnet to: fedworld.gov
Select the option: [1] FedWorld
Logon to the FedWorld system
Type: /go FERC
Or:
Point your Web Browser to: http://www.fedworld.gov
Scroll down the page to select FedWorld Telnet Site
Select the option: [1] FedWorld
Logon to the FedWorld system
Type: /go FERC
NOTICE OF PROPOSED RULEMAKING
April 24, 1996.
I. Introduction
The Federal Energy Regulatory Commission (Commission) is proposing
to amend its open access regulations to standardize business practices
and procedures governing transactions between interstate natural gas
pipelines, their customers, and others doing business on the pipelines.
The proposed standards govern four important business practices--
nominations; allocations, balancing, and measurement; invoicing; and
capacity release--as well as the mechanisms for electronic
communication between the pipelines and those doing business on the
pipelines. The proposed regulations incorporate by reference the
standards submitted by the Gas Industry Standards Board (GISB) in
response to the Commission's October 25, 1995 Advanced Notice of
Proposed Rulemaking (ANOPR).\1\ The Commission proposes to require
pipelines to comply with the regulations by January 1, 1997.
---------------------------------------------------------------------------
\1\ Standards For Business Practices Of Interstate Natural Gas
Pipelines, 60 FR 55504 (Nov. 1, 1995), 73 FERC para. 61,104 (Oct.
25, 1995). Public Reporting Burden
---------------------------------------------------------------------------
II. Public Reporting Burden
The proposed rule would require natural gas pipelines to adopt both
standards for business practices and procedures as well as mechanisms
for electronic communication between pipelines and those doing business
with the pipelines. The standards would regularize the means by which
the gas industry conducts business across the interstate pipeline grid.
The standards were developed by GISB, an industry consensus standards
organization, to improve the efficiency of the gas market. The
Commission is proposing to adopt these standards by reference.
The proposed rule would affect one existing Commission data
collection, FERC-545, Gas Pipeline Rates: Rate Change (Non-formal),
(OMB Control No. 1902-0154) (FERC-545), and establish a new data
collection/requirement, FERC-549C, Standards for Business Practices of
Interstate Natural Gas Pipelines, (OMB Control No. to be assigned)
(FERC-549C).
Under the existing data collection/requirements of FERC-545, there
would be a one-time estimated annual reporting burden of 6,400 hours
(80 hours per company) with the adoption of the standards/business
practices as proposed herein. The initial implementation of the
proposed standards/business practices would require approximately 80
interstate natural gas pipelines to make tariff filings to conform
their tariffs with the standards/business practices. (See FERC-545
burden detail in estimated burden table below.)
Under the new data collection/requirements of FERC-549C there would
be a one-time start-up annual burden/cost of 1,227,840 hours (15,348
per company). It is expected that any recurring annual burden/cost
would not be substantial given the operating efficiencies which would
result from the proposed standards/business practices, particularly the
improved methods of electronic communication.
The proposed standards/data requirements contained in this Notice
of Proposed Rulemaking have been submitted to the Office of Management
and Budget for review under section 3507(d) of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3507(d). For copies of the OMB submission,
contact Michael Miller at 202-208-1415. Comments are solicited on the
Commission's need to require the industry to adopt the standards/
business practices on an industry-wide basis; whether the proposed
requirements will have practical utility; the accuracy of the provided
burden estimates; ways to enhance the quality, utility, and clarity of
the proposed data requirements; and any suggested methods for
minimizing respondents' burden including the use of automated
techniques. Persons wishing to comment on the proposed information
requirements should direct their comments to the Desk Officer FERC,
Office of Management and Budget, Room 3019 NEOB, Washington, D.C.
20503, phone 202-395-3087 or via the Internet at [email protected].
GISB and others in the natural gas industry have requested
expedited processing of this proposed rule, and the Commission has
requested the Office of Management and Budget (OMB) to provide for
emergency processing of this proposed collection of information by May
24, 1996. Comments on the collection of information, therefore, should
be filed with the Office of Management and Budget as soon as possible
to provide OMB sufficient time for its review. A copy of any comments
filed with the Office of Management and Budget also should be sent to
the following address at the Commission: Federal Energy Regulatory
Commission, Information Services Division, Room 41-17, Washington, DC
20426, Attention: Michael Miller.
Estimated Annual Burden
----------------------------------------------------------------------------------------------------------------
Total Total
Affected data collection/requirement Number of number of Hours per annual
respondents responses response hours
----------------------------------------------------------------------------------------------------------------
FERC-549C (New Data Requirement):
Reporting/Data Requirement Burden....................... 80 80 15,348 1,227,840
[[Page 19213]]
FERC-545 (1902-0154):
Reporting/Data Requirement Burden....................... 80 80 80 6,400
---------------------------------------------------
Total Annual Hours (All Data Collections/
Requirements)...................................... 80 80 15,428 1,234,240
----------------------------------------------------------------------------------------------------------------
Data Collection/Requirement Costs: The Commission seeks comments on
the costs to comply with these proposed standards/business practices.
It has projected that the average annualized cost per respondent for
the first year would be as follows:
Annualized Capital/Start-up Costs
FERC-549C.................................................. $750,118
FERC-545................................................... 3,910
----------
Total.................................................... 754,028
Internal Review: The Commission has reviewed, in general, the
proposed standards/business practices and determined that they are
necessary to establish a more efficient and integrated pipeline grid.
Requiring such standards on an industry-wide basis would reduce the
variations in pipeline business practices and, thus, enable buyers to
more easily and efficiently buy and transport gas from all potential
sources of supply. The proposed standards/business practices conform to
the Commission's plan for efficient information collection,
communication, and management within the natural gas industry. The
Commission has assured itself, by means of its internal review, that
there is specific, objective support for the burden estimates
associated with the information requirements proposed in this Notice of
Proposed Rulemaking (NOPR).
III. Background
The process of standardizing business practices in the natural gas
industry began with a Commission initiative to convene a technical
conference to standardize electronic communication of capacity release
transactions.\2\ To develop the required standards, the participants at
the conference agreed to form working groups composed of
representatives from all segments of the industry. In addition to the
capacity release standards, the conference participants decided that
standardization of other business transactions, such as nominations and
flowing gas, was important and formed an additional Working Group to
begin to develop standards for these transactions. A consensus of the
Working Group recommended that the industry be permitted to develop and
implement such standards voluntarily. Thus, while the Commission
recognized the importance of this effort in helping to facilitate gas
movement across the pipeline grid, the Commission was not actively
involved in the process.\3\ The Commission pledged to reevaluate its
role in the development and implementation of such standards based on
the progress made by the industry.
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\2\ Standards For Electronic Bulletin Boards Required Under Part
284 of the Commission's Regulations, Order No. 563, 59 FR 516 (Jan.
5, 1994), III FERC Stats. & Regs. Preambles para. 30,988 (Dec. 23,
1993), order on reh'g, Order No. 563-A, 59 FR 23624 (May 6, 1994),
III FERC Stats. & Regs. Preambles para. 30,994 (May 2, 1994), reh'g
denied, Order No. 563-B, 68 FERC para. 61,002 (1994).
\3\ Order No. 563-A, III FERC Stats. & Regs. Preambles, at
31,050.
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During this same time frame, the industry sought to formalize the
Working Group process by forming a private standards organization to
continue and expand the Working Groups' efforts to develop electronic
standards. In 1995, the industry formed GISB as a consensus standards
organization open to all members of the gas industry.\4\ GISB's
procedures require balanced voting representation from all five
segments of the industry--pipelines, local distribution companies
(LDCs), producers, end-users, and services (including marketers and
third-party computer service providers). At the Executive Committee
level, a consensus of the five segments must approve each standard.\5\
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\4\ According to a March 27, 1996 letter from counsel for GISB,
to the Secretary of the Commission (filed in this docket), GISB has
not yet received approval by the American National Standards
Institute (ANSI) as an accredited standards organization due to a
misunderstanding between GISB and ANSI. GISB is now pursuing ANSI
accreditation, and, according to GISB, ANSI has agreed to expedite
its review of GISB's application. Accreditation involves, among
other items, ANSI's review of the process and procedures of the
standards-developers to ensure that the standards-development
process is open to all materially affected parties and that
standards are developed by a balanced consensus of the industry,
without domination by any single interest or interest category.
\5\ To pass the Executive Committee, a standard must be approved
by 17 out of the 25 members, with at least two affirmative votes
from each segment. These standards must then be approved by a vote
of 67% of GISB's general membership to become approved standards.
---------------------------------------------------------------------------
In addition, the industry, under the auspices of the Interstate
Natural Gas Association of America (INGAA) and the Associated Gas
Distributors (AGD), began a Grid Integration Project to consider
standards for coordinating pipeline business practices to simplify the
process of shipping gas across multiple pipelines. After GISB expanded
its scope from electronic standards to encompass business practice
standards, the Grid Integration Project was folded into GISB.
On September 21, 1995, the Commission held a public conference in
Docket No. RM93-4-000 to evaluate the progress being made towards
standardization. Almost all the commenters at the conference
acknowledged that the industry had not achieved the anticipated
progress. Many participants maintained that merely standardizing
electronic communication did not go far enough to provide for efficient
integration of the pipeline grid. Even though GISB had promulgated
standards for electronic communication of nomination and confirmation
information, the participants contended these standards were not being
widely used because they failed to standardize the pipelines' disparate
underlying business practices. For example, pipelines often require
vastly different information to submit a valid nomination, so that,
even if nominations are submitted electronically, efficiency would be
impaired because the shippers' schedulers would have to know the
idiosyncratic nomination and confirmation information for each
pipeline.
On October 25, 1995, the Commission issued an advance notice of
proposed rulemaking requesting the submission of detailed proposals
from the industry, by March 15, 1996, that would enable the Commission
to adopt regulations for business practices and procedures involving
transactions between pipelines and their customers. In the ANOPR, the
Commission concluded that without common business practices
[[Page 19214]]
and a common language for communication, the speed and efficiency with
which shippers can transact business across multiple pipelines is now,
and will continue to be, severely compromised.
The Commission sought detailed proposals in four areas: (1) The
standard set of information (data elements) that pipelines must use in
conducting ten high priority business transactions identified by the
industry--nominations, confirmations, allocated gas flows, customer and
contract imbalances, gas flow at metered points, transportation
invoices, pre-determined allocation methodologies, gas payment
remittance statements, gas sales invoices, and uploads of capacity
release prearranged deals; (2) standards covering nomenclature and any
business practices associated with the ten elements; (3) standard
methods of communicating the information, including communication
protocols for each business practice that address issues such as
scheduling and response times of information exchanges and performance
standards for assessing whether the system is substantially meeting
those goals; 6 and (4) standards needed to facilitate gas flow
across interconnecting pipelines, such as those considered by the Grid
Integration Project.
---------------------------------------------------------------------------
\6\ The Commission also invited the submission of alternatives
to the current requirement that pipelines provide information
through an Electronic Bulletin Board (EBB). See 18 CFR 284.8(b)(4).
---------------------------------------------------------------------------
The Commission established January 1, 1997 as the target deadline
for compliance with the standards, and urged the segments of the
industry to work together, as they had during the Working Group
process, to achieve consensus on the standards. The Commission
anticipated that GISB would become the forum for coordinating these
industry efforts, and stated it would give great weight to consensus
proposals emanating from the GISB process.
On March 15, 1996, GISB filed 140 standards covering five major
business areas--nominations and confirmations, flowing gas, invoicing,
capacity release, and the electronic mechanism for communication
between industry participants (the electronic delivery mechanism
(EDM)). Over 500 individuals participated in the effort to develop
these standards, with 45 days of meetings conducted over a period of 53
business days. The GISB Executive Committee, through its consensus
voting procedures, approved these standards. According to GISB, these
standards are intended to be minimum standards that parties are
encouraged to exceed by providing enhanced services or faster response
times. On March 15, GISB also filed a draft set of data elements
describing the specific information that would be used by industry
participants to conduct the 10 high priority business transactions.
Subsequently, on April 9, 1996, GISB's Executive Committee approved
the final version of the data sets. GISB filed the data sets with the
Commission on April 12, 1996, along with a revision to business
practice standard 1.2.2 to clarify the usage codes employed in the data
sets. GISB explains that the data sets are to be implemented using the
current PI-GRIDTM and DUNS numbers.7 GISB reports that, as
part of its process of trying to improve the standards, the Executive
Committee unanimously has adopted the recommendation of its Common
Codes Subcommittee to revise and enhance the common code structures to
produce greater efficiency.
---------------------------------------------------------------------------
\7\ The PI-GRIDTM number is maintained by the Petroleum
Information Corporation pursuant to a contract with major gas
industry trade associations to provide and maintain a common code
database. The DUNS number refers to the company codes published by
Dun & Bradstreet Corporation. See Order No. 563-A, III FERC Stats. &
Regs. Preambles, at 31,043.
---------------------------------------------------------------------------
GISB also states that it has begun the process of mapping the data
sets into ASC X12 language and preparing an implementation guide.8
GISB states that its task forces have committed to completing this
effort by May 31, 1996. GISB notes that if this effort reveals the need
for changes to the data sets, it will so inform the Commission.
---------------------------------------------------------------------------
\8\ ASC X12 is a standardized format for electronic transmission
of documents. Standards for the use of such documents are
promulgated by the ANSI Accredited Standards Committee (ASC).
---------------------------------------------------------------------------
GISB says it mailed out ballots to its membership on April 12,
1996, for ratification of the business practice standards and data
sets. An affirmative vote by 67% of those returning ballots is needed
for ratification, and members have 30 days to respond.
On March 15, 1996 (or shortly thereafter), 40 parties filed
comments on the GISB standards.9 On the whole, the commenters
found that GISB's standards would significantly improve the efficiency
of the gas market, but they raised questions with respect to specific
standards.
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\9\ The appendix lists those filing comments.
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IV. Discussion
A. Proposed Incorporation of the GISB Standards by Reference
The Commission commends the industry and GISB for the work they
have put into this process and the significant progress they have made
towards standardization. GISB's standards go beyond merely
standardizing the data sets for electronic communication of the ten
high priority data elements; the standards regularize the means by
which the entire industry will conduct business across the interstate
pipeline grid.
The following is just a small sample of what would be accomplished
by the adoption of these standards. All pipelines would permit pooling
on their systems, which will simplify nominations by permitting
producers and shippers to aggregate gas packages. All pipelines would
permit at least one intra-day nomination, which will allow shippers to
change the amount of gas they receive during a day to better fit
changing needs. All pipelines would adopt a standard set of information
covering the ten high priority data elements, so that shippers will be
able to communicate using the same information for the same
transactions no matter the pipelines with which they deal. And all
pipelines would support a standard Internet connection for
communications with their customers, eliminating the disparity in log-
in procedures and user interfaces faced by customers using the
individual pipeline electronic bulletin boards.
The GISB standards represent a formidable step towards improved
efficiency and competitiveness in the gas industry. Accordingly, the
Commission is proposing to require interstate pipelines to comply with
the GISB definitions, standards, and data sets by January 1,
1997.10 Pipelines also may need to make tariff filings to amend
current tariffs in sufficient time to comply with the new standards.
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\10\ The Commission is not proposing to adopt the principles
articulated by GISB, because these do not purport to impose
obligations on pipelines. The principles, however, will be used as
guidance as to the intent of the standards.
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To adopt the GISB standards, the Commission proposes to add section
284.10 to its regulations. Section 284.10(b) would incorporate the GISB
definitions, standards, and data sets by reference. GISB's previously
approved standards for capacity release transactions also would replace
the current requirement, in section 284.8(b)(5), that pipelines comply
with standardized data sets and communication protocols. In addition,
the EBB requirements of sections 284.8(b)(4) and 284.9(b)(4) would be
moved to section 284.10(a).
Incorporation of the GISB standards by reference is consistent with
the public policy of having federal agencies rely upon voluntary
private standards
[[Page 19215]]
whenever feasible.11 Even though the Commission is proposing to
incorporate the standards by reference, the Commission retains the
ability, if it deems necessary, to modify pipelines' obligations by
specifying in the regulations any deletions of, or revisions or
additions to the GISB standards.
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\11\ See National Technology Transfer and Advancement Act of
1995, Pub L. 104-113, Sec. 12(d), 110 Stat. 775 (1996), and OMB
Circular A-119, ``Federal Participation in the Development and Use
of Voluntary Standards'' (Oct. 20, 1993) (an earlier version is
available at 47 FR 49496 (Nov. 1, 1992)).
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In its March 15, 1996 filing, GISB asserts that major efforts are
required by all segments of the industry to meet the Commission's
proposed January 1, 1997 compliance date. GISB, therefore, requested
the Commission to issue its NOPR and final rule as quickly as
procedural rules permit, with a target date of May 31, 1996, for
issuance of the final rule.
Since GISB did not submit the data sets until April 12, 1996, and
final approval of the business practice standards and the data sets by
the GISB members will not take place until mid-May 1996, the Commission
cannot meet the suggested May 31, 1996 date and still afford a
meaningful opportunity for comment.12 The Commission, however,
recognizes the importance of this undertaking and is committed to
moving this proceeding as quickly as possible. The Commission, for
example, is issuing this NOPR at the earliest opportunity after having
received GISB's final data sets.
---------------------------------------------------------------------------
\12\ Although GISB fully expects membership approval of the
standards, the Commission's 30 day comment period in this proceeding
affords an opportunity for comment in the event that the membership
vote results in any changes or revisions to the standards.
---------------------------------------------------------------------------
GISB states that the standards were based on the Commission's
January 1, 1997 target compliance date, with the exception of the
Internet protocols, for which GISB proposes a compliance date of April
1, 1997. Other commenters, however, expressed concern about the effect
on shippers and consumers if pipeline compliance is set for January 1,
1997, and failures occur during the midst of the winter heating season.
The Commission considers prompt implementation of these standards
to be a high priority for the industry and does not want to unduly
delay the beneficial effects of implementing these standards. Affected
parties are fully aware of the standards and can begin to plan for
implementation now. The Commission, therefore, proposes to adhere to
the January 1, 1997 compliance date. The Commission recognizes,
however, the concerns expressed by some parties regarding mid-winter
implementation. Parties objecting to this proposed date for compliance
should provide a fully developed staggered implementation plan or other
approach that will ensure rapid implementation of the most important
standards. INGAA, for instance, submitted a proposed phased
implementation plan that puts off implementation of some of the
important nomination and other standards until June of 1997. The
Commission believes this is too long.
Adoption of the GISB standards does not mean that the work of
standardization is done. As GISB and the industry recognize,
standardization is an ongoing, continuous process and not all the
needed standards could be developed within the timeframe established by
the Commission in the ANOPR. The Commission, therefore, is also setting
September 30, 1996 as a date for GISB and the industry to submit
detailed proposals for standards in the additional areas identified by
GISB and the commenters, such as expansion of Internet protocols to
include all electronic information provided by the pipelines (perhaps
to replace pipeline cost-of-service EBBs13), title transfer
tracking, allocations and rankings of gas packages, treatment of
compressor fuel, operational balancing agreements, routing models,
imbalance resolution, operational flow orders, multi-tiered allocations
and confirmations, and additional pooling standards.
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\13\ 18 CFR 161.3(h), 250.16(c)(2)284.8(b)(4), 284.106(c)(4),
284.223(b) (requiring pipelines to post capacity information,
affiliate discount reports, the affiliate capacity allocation log,
and an index of customers on EBBs).
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B. Electronic Delivery Mechanism
GISB has not yet completed the technical process of mapping the
data sets to the ASC X12 formats and preparing the associated
implementation guide, but has committed to do so by May 31, 1996. The
Commission expects that these documents will go through the GISB
consensus process for obtaining industry input and approval. Once
completed, the Commission proposes to incorporate these documents in
its regulations.
In addition, GISB's standard for providing for Internet
communication is tentative and depends on the outcome of further
examination of security and other issues. The Commission requests
comment from GISB and others specifying the delivery mechanism and
related standards and protocols that would be used on January 1, 1997,
if the Internet approach is not adopted. Comments also should address
whether additional standards are needed for Internet communication,
such as the use of file transfer protocol (FTP), and the timetable for
developing those standards.
C. Comments
The comments on the GISB standards that were received
contemporaneously with GISB's filing fall into essentially four
categories: Suggestions to delete or revise standards; requests for
clarification as to the scope of standards; requests for waivers; and
requests for additional standards that GISB either did not adopt or did
not consider. Given the information the Commission has at this point in
the process, the objections raised do not appear to justify any change
or revision to the industry's consensus proposals in this NOPR. A
benefit of having these comments is that they may help focus the
industry's comments on this proposed rule.
1. Requests for Revisions
Since a consensus of all segments of the natural gas industry has
found that the standards are necessary and achieve a reasonable balance
between the needs of all segments and areas of the country, the
Commission is hesitant to revise them. The industry, not the
Commission, is in the best position to evaluate and balance the
industry's concerns, and the Commission sees no evidence that an
appropriate balance has not been struck. For example, some LDCs and
shippers on the West Coast contend their efficiency would be improved
by moving the start of the nomination process from 11:30 a.m. to 12:30
p.m. Iroquois, on the other hand, contends that 10:30 a.m. would be
preferable for East Coast shippers. Similarly, several Midwest LDCs
contend their pipelines' previous 12:00 noon gas day makes their
nomination and scheduling process easier than GISB's 9:00 a.m. gas day,
but apparently the rest of the industry prefers the 9:00 a.m. gas day.
The GISB standards, therefore, appear to effect a reasonable compromise
between the positions of the various industry segments. 14
---------------------------------------------------------------------------
\14\ The GISB standards do not appear to preclude the Midwest
LDCs from reaching agreements with their pipelines to provide
greater nomination flexibility if that is required in their region.
---------------------------------------------------------------------------
Some commenters are concerned that GISB's deadlines do not provide
sufficient flexibility. NGC/Conoco/Vastar/Coastal contend uniform
nomination deadlines should not be adopted; they prefer varied
nomination schedules, because, they argue, varied schedules would
permit parties bumped on one pipeline to renominate on other pipelines.
[[Page 19216]]
The GISB standards, however, do not appear to unduly restrict
flexibility. The standards would require each pipeline to permit one
intra-day nomination four hours prior to gas flow. The standards also
establish a seven-day-a-week, 24-hour-a-day nomination process and
specify that nominations submitted after the nomination deadline should
still be processed by the pipeline. Thus, as long as pipelines have
available capacity, shippers should be permitted to nominate gas on
those pipelines even if the nomination deadline has passed or they have
not previously submitted a nomination for that day. The Commission
solicits comments as to whether this interpretation is correct or
whether an additional standard may be needed requiring pipelines to
permit nominations any time they have unscheduled capacity.
Of course, during the comment period, GISB and the industry have an
additional opportunity to review the standards that have been
challenged and submit revisions. The Commission also will be able to
review these matters again in light of comments on both sides of the
issues.
In addition, the Commission requests clarification of GISB's
statement that all of its standards should be considered minimums and
that parties are encouraged to exceed these standards. The Commission
is not sure whether GISB intends that pipelines and their customers can
mutually agree to change all of the GISB standards or whether some
standards should be considered inviolate, because any change would have
adverse repercussions for non-contracting parties.
2. Requests for Clarification
The requests for clarification generally involve questions about
how the standards are to be implemented. For instance, some shippers
contend that GISB's standard for one intra-day nomination should apply
to all receipt and delivery points and all services, while others
contend that pipelines should be permitted to offer services without
this flexibility for a lower price. CNG Transmission similarly contends
that the requirement for pipelines to provide pooling should apply only
to direct feed deliveries, not to supplies received from upstream
pipelines.
The Commission expects pipelines to make a good faith effort to
implement these standards as broadly as possible to provide their
customers with the services they need to operate in an integrated gas
market. Providing more specific answers to implementation questions may
not be possible on a generic basis, since operational conditions and
customers' requirements may differ depending on the pipelines. The
Commission expects pipelines to consult, and reach agreement, with
their shippers on the mechanics of implementation. This process should
resolve most of these disputes. But, if problems still exist, the
Commission can address them when pipelines file revised tariffs to
incorporate the standards or through the complaint process.
3. Requests for Waivers
Several pipelines have requested waivers of certain standards that
they find impractical on their systems. In particular, they argue that
they may not be able to provide, with their current equipment, certain
measurement data as quickly as the standards specify. They maintain
that installing updated equipment would be unnecessarily expensive.
As a general matter, the Commission is hesitant to grant exceptions
to industry-wide standards, because such exceptions run counter to the
reason for establishing standards in the first place: that the industry
requires uniform procedures to achieve the greatest efficiency in
transporting gas across an integrated pipeline grid. The Commission,
however, will consider requests for waivers based on the facts of the
individual situation. Agreement to a waiver by a pipeline's customers
would be an important factor in considering any waiver request.
4. Requests for Additional Standards
GISB recognizes that additional work is needed to consider
standards in the additional areas listed earlier, 15 but has not
yet established deadlines for consideration of such standards. A number
of the commenters argue that standards in these areas are extremely
important, but they do not suggest that development of standards in
these areas is a prerequisite to implementation of the current GISB
standards.
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\15\ See text accompanying note 13, supra.
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The Commission recognizes that, in the time provided, the industry
could not reach agreement on all the issues necessary to enhance the
efficiency of the gas marketplace. Although adoption of standards in
these additional areas need not take place coincident with the
standards GISB has filed, prompt attention to these issues appears
important to the continued development of an efficient gas marketplace.
For a fully competitive gas market to exist, participants need to be
able to buy and sell gas freely. The ability do so, however, can be
restricted if these transactions are not accurately reflected in the
scheduling, confirmation, and accounting procedures used by the
industry. Similarly, shippers should be able to contract for gas at a
lower price if they are willing to assume a greater risk of
curtailment. Thus, shippers and producers must be able to assign
different priorities to gas packages to reflect those choices.
The industry is better able than the Commission to craft solutions
that will most effectively resolve the issues at the lowest overall
cost. Now that the press of developing the bulk of the standards has
receded, the Commission expects the industry to focus its attention on
these additional areas. The Commission recognizes that some of these
issues are complex and have vexed the industry for some time. But that
is all the more reason for all segments of the industry and GISB to
continue to work cooperatively and creatively to develop solutions that
fairly balance the concerns of all the participants. For example, when
faced with the task of creating a database for common transaction
points, the industry decided upon a nationwide solution by using the
Petroleum Information Corporation to create and administer the common
code data base. Similar creativity should be employed here.
Because of the importance shippers place on resolving these issues,
the Commission is soliciting detailed proposals for standards in these
areas from GISB and the industry, by September 30, 1996. The Commission
would prefer that the industry reach consensus agreement through GISB
on proposed standards (or a consensus that a standard is not needed).
However, if with this additional time, the industry is unable to reach
consensus, the Commission is willing to resolve these issues. In the
event consensus is not reached, the Commission will expect the
September 30, 1996 reports to be sufficiently comprehensive that they
fully describe the problems faced by the industry and explain whether a
uniform response is needed or not, discuss the potential solutions to
the problems that have been considered, and provide analysis of the
benefits and disadvantages of the proposed solutions.
D. Capacity Release
The Commission has been examining the operation of its capacity
release mechanism in a number of proceedings.16 As part of this
process,
[[Page 19217]]
Commission staff, in the fall of 1994, conducted informal discussions
with all segments of the gas industry about the way in which the system
operates, discussions which helped form the basis for changes in the
program.17
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\16\ Release of Firm Capacity on Interstate Natural Gas
Pipelines, Order No. 577, 60 FR 16979 (Apr. 4, 1995), III FERC
Stats. & Regs. Preambles para. 31,017 (Mar. 29, 1995). See also
Petition Of United Distribution Companies and Associated Gas
Distributors For A Rulemaking To Promote Growth And Development Of
The Secondary Market, Docket No. RM94-10-000, filed December 9,
1993.
\17\ See Order No. 577, III FERC Stats. & Regs. Preambles at
31,313.
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Although GISB did not propose changes to the major policy aspects
of the Commission regulations (such as the cap on the price for
released capacity and the requirement for bidding on pipeline
EBBs18), GISB did address important issues regarding the operation
of the capacity release program. Of particular interest, GISB proposes
a standard timeframe within which pipelines would process capacity
release transactions and has created standardized data sets permitting
uploads of capacity release transactions. Under GISB's timeline,
replacement shippers would be able to nominate under a short-term
release (less than five months) within one day of notifying the
pipeline of the release.19 This same schedule applies whether the
release is subject to bidding or is exempt from the bidding
process.20
---------------------------------------------------------------------------
\18\ 18 CFR 284.243.
\19\ Specifically, pipelines would need to be notified by 1 p.m.
for shippers to nominate the next day.
\20\ Capacity release deals are exempt from bidding if they are
for a period of 31 days or less or are at the maximum rate. 18 CFR
284.243(h).
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To assist in the Commission's consideration of the capacity release
mechanism, the Commission is requesting comment on how adoption of
GISB's proposals would affect concerns previously expressed about the
capacity release program. Comments should not focus on whether the
Commission should revise its basic capacity release policies, such as
the price cap or bidding, but should center on the effect of adopting
the GISB standards on previously identified problems with the capacity
release system. Comments should address how effectively GISB's
proposals deal with concerns about the speed and other mechanics of the
pipeline bidding process, the difficulty in coordinating releases
across multiple pipelines, and the lack of comparability between the
capacity release procedures and the process of obtaining pipeline
interruptible or short-term firm capacity.
Few comments address GISB's capacity release provisions.
TransCapacity requests clarification of standard 5.3.11 which states
that ``replacement shipper initiates confirmation of prearranged deals
electronically.'' TransCapacity contends that the standard, as worded,
does not require pipelines to accept replacement shipper confirmations
through file uploads; it would permit pipelines to specify EBB
confirmations or some other electronic means.
TransCapacity appears to raise a valid concern. The reason for
developing standardized data sets for uploads of pre-arranged deals was
to increase the efficiency of the capacity release mechanism by
permitting parties to avoid the use of pipeline EBBs to transmit
release transactions to the pipelines. On some pipelines, apparently,
submission of the pre-arranged deal is not sufficient to conclude the
transaction; the pipeline requires the replacement shipper to confirm
that transaction. Comments should consider whether the efficiency
sought to be achieved through uploads of pre-arranged deals would be
compromised if pipelines are not required to permit uploads of
confirmations by the replacement shipper or its agent.
INGAA suggests that the Commission consider removing the
requirement that bidding take place through the pipeline and, instead,
establish a mechanism under which bidding could take place through
third-party computer service providers. Comments should address whether
this proposal would introduce greater efficiency in the capacity
release system. One of the principal arguments for permitting bidding
on third-party boards was that third-parties have an incentive to
process transactions much faster than the pipelines, which sometimes
had bidding and posting periods lasting several days. GISB's standards
would require pipelines to process bids in one day, and comments should
address whether this change reduces the need for third-party bidding.
In addition, comments should consider the possible effect on releasers
and replacement shippers if, instead of having the assurance that all
biddable deals for a pipeline are posted on that pipeline's system,
they also have to monitor postings on third-party boards.
V. Environmental Analysis
The Commission is required to prepare an Environmental Assessment
or an Environmental Impact Statement for any action that may have a
significant adverse effect on the human environment.\21\ The Commission
has categorically excluded certain actions from these requirements as
not having a significant effect on the human environment.\22\ The
action taken here falls within categorical exclusions in the
Commission's regulations for rules that are clarifying, corrective, or
procedural, for information gathering, analysis, and dissemination, and
for sales, exchange, and transportation of natural gas that requires no
construction of facilities.\23\ Therefore, an environmental assessment
is unnecessary and has not been prepared in this rulemaking.
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\21\ Order No. 486, Regulations Implementing the National
Environmental Policy Act, 52 FR 47897 (Dec. 17, 1987), FERC Stats. &
Regs. Preambles 1986-1990 para. 30,783 (1987).
\22\ 18 CFR 380.4.
\23\ See 18 CFR 380.4(a)(2)(ii), 380.4(a)(5), 380.4(a)(27).
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VI. Regulatory Flexibility Act Certification
The Regulatory Flexibility Act of 1980 (RFA) \24\ generally
requires a description and analysis of final rules that will have
significant economic impact on a substantial number of small entities.
The proposed regulations would impose requirements only on interstate
pipelines, which are not small businesses, and, these requirements are,
in fact, designed to reduce the difficulty of dealing with pipelines by
all customers, including small businesses. Accordingly, pursuant to
section 605(b) of the RFA, the Commission hereby certifies that the
regulations proposed herein will not have a significant adverse impact
on a substantial number of small entities.
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\24\ 5 U.S.C. 601-612.
---------------------------------------------------------------------------
VII. Information Collection Requirement
The Commission considers the prompt implementation of these
standards to be a high priority for the industry, and GISB and others
in the natural gas industry have requested that the Commission process
this proposed rule as quickly as possible. The Commission believes that
the normal clearance procedures for review and approval by the Office
of Management and Budget (OMB) could delay the proposed date for
pipelines to comply with the rule. Therefore, the Commission is
submitting this proposed information collection/requirement for
emergency processing under Section 5 CFR 1320.13 of OMB's regulations.
The Commission requests OMB to approve the proposed data collection
requirements no later than 5 p.m., May 24, 1996. Comments to OMB
regarding the subject NOPR should be sent as soon as possible in order
that OMB have sufficient time for its review.
Title: FERC-545, Gas Pipeline Rates: Rate Change (Non-formal).
[[Page 19218]]
Action: Proposed Data Collection/Requirements.
OMB Control No.: 1902-0154.
Docket No.: RM96-1-000.
Respondents: Interstate Natural Gas Pipelines (Not applicable to
small businesses).
Frequency of Responses: One-time tariff filings (First year).
Title: FERC-549C, Standards for Business Practices of Interstate
Natural Gas Pipelines.
Action: Proposed Data Collection/Requirements.
OMB Control No.: To be assigned by OMB.
Respondents: Interstate Natural Gas Pipelines (Not applicable to
small businesses).
Frequency of Responses: One-time capital/start-up new business
procedures (First year).
Necessity of Information: The Notice of Proposed Rulemaking
solicits public comments to respond to the standards proposed to be
established to govern four major business practices--nominations;
allocations, balancing, and measurement; invoicing; and capacity
release--as well as the mechanism for electronic communication between
the pipelines and those doing business with the pipelines. The proposed
data requirements incorporate by reference the standards submitted by
GISB. Without the Commission's adoption of these standards to establish
common business practices and a common language for communication
across the pipeline grid, the speed and efficiency with which shippers
can transact business across multiple pipelines would be severely
compromised. Under the proposed rule, all pipelines would adopt a
standard set of information covering the ten high priority data
elements, so that shippers would be able to communicate using the same
information for the same transactions regardless of the pipelines with
which they are dealing. In addition, all pipelines would support a
standard Internet connection for communications with their customers,
eliminating the disparity in log-on procedures and user interfaces
faced by customers using the individual pipeline electronic bulletin
boards.
The Office of Management and Budget's (OMB) regulations require OMB
to approve certain information collection requirements imposed by
agency rule.\25\ The information collection requirements in the
proposed rule would be reported directly to the industry users. The
implementation of these proposed data requirements will help the
Commission carry out its responsibilities under the Natural Gas Act and
coincide with the current regulatory environment which the Commission
instituted with Order No. 636 and the restructuring of the natural gas
industry. The Commission's Office of Pipeline Regulation uses the data
in rate proceedings to review rate and tariff changes by natural gas
companies for the transportation of gas and for general industry
oversight.
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\25\ 5 CFR 1320.11.
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The Commission is submitting notification of this proposed rule to
OMB for emergency processing. Interested persons may obtain information
on the reporting requirements by contacting the Federal Energy
Regulatory Commission, 888 First Street N.E., Washington, DC 20426
[Attention: Michael Miller, Information Services Division, (202) 208-
1415] or the Office of Management and Budget [Attention: Desk Officer
for the Federal Energy Regulatory Commission (202) 395-3087].
VIII. Comment Procedures
The Commission invites interested persons to submit written
comments on the matters proposed in this notice, including any related
matters or alternative proposals that commenters may wish to discuss.
The Commission also invites commenters to address the comments already
filed in this proceeding and discuss why they may support the standards
filed by GISB. An original and 14 copies of comments to this notice
must be filed with the Commission no later than May 24, 1996. Comments
should be submitted to the Office of the Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE, Washington, DC 20426, and
should refer to Docket No. RM96-1-000. Additionally, comments should be
submitted on computer diskette in WordPerfect 5.1 format or in ASCII
format, with the name of the filer and Docket No. RM96-1-000 on the
outside of the diskette.
All written comments will be placed in the Commission's public
files and will be available for inspection in the Commission's Public
Reference Room at 888 First Street, NE, Washington, DC 20426, during
regular business hours.
List of Subjects
18 CFR Part 161
Natural gas, Reporting and recordkeeping requirements.
18 CFR Part 250
Natural gas, Reporting and recordkeeping requirements.
18 CFR Part 284
Continental shelf, Natural gas, Reporting and recordkeeping
requirements; Incorporation by reference.
By direction of the Commission.
Lois D. Cashell,
Secretary.
In consideration of the foregoing, the Commission proposes to amend
Parts 161, 250, and 284, Chapter I, Title 18, Code of Federal
Regulations, as set forth below.
PART 161--STANDARDS OF CONDUCT FOR INTERSTATE PIPELINES WITH
MARKETING AFFILIATES
1. The authority citation for Part 161 continues to read as
follows:
Authority: 15 U.S.C. 717-717w, 3301-3432; 42 U.S.C. 7101-7352.
Sec. 161.3 [Amended]
2. In Sec. 161.3, paragraph (h)(2) is amended by removing the
phrase ``Sec. 284.8(b)(4)'' and adding, in its place, the phrase
``Sec. 284.10(a)''.
PART 250--FORMS
1. The authority citation for Part 250 continues to read as
follows:
Authority: 15 U.S.C. 717-717w, 3301-3432; 42 U.S.C. 7101-7352.
Sec. 250.16 [Amended]
2. In Sec. 250.16, paragraph (c)(2) is amended by removing the
phrase ``Sec. 284.8(b)(4)'' and adding, in its place, the phrase
``Sec. 284.10(a)''. ,
PART 284--CERTAIN SALES AND TRANSPORTATION OF NATURAL GAS UNDER THE
NATURAL GAS POLICY ACT OF 1978 AND RELATED AUTHORITIES
1. The authority citation for Part 284 continues to read as
follows:
Authority: 15 U.S.C. 717-717w, 3301-3432; 42 U.S.C 7101-7532; 43
U.S.C 1331-1356.
2. In Sec. 284.8, paragraphs (b)(4) and (b)(5) are removed,
paragraph (b)(6) is redesignated (b)(4), and paragraph (b)(3) is
revised to read as follows:
Sec. 284.8 Firm transportation service.
* * * * *
(b) * * *
(3) An interstate pipeline that offers transportation service on a
firm basis under subpart B or G of this part must provide all shippers
with equal and timely access to information relevant to the
availability of such service, including, but not limited to, the
[[Page 19219]]
availability of capacity at receipt points, on the mainline, at
delivery points, and in storage fields, and whether the capacity is
available directly from the pipeline or through capacity release. The
information must be provided on an Electronic Bulletin Board with the
features prescribed in Sec. 284.10(a) and as required by
Sec. 284.10(b).
* * * * *
3. In Sec. 284.9, paragraph (b)(4) is removed, paragraph (b)(5) is
redesignated (b)(4), and paragraph (b)(3) is revised to read as
follows:
Sec. 284.9 Interruptible transportation service
* * * * *
(b) * * *
(3) An interstate pipeline that offers transportation service on an
interruptible basis under subpart B or G of this part must provide all
shippers with equal and timely access to information relevant to the
availability of such service. The information must be provided on an
Electronic Bulletin Board with the features prescribed in
Sec. 284.10(a) and as required by Sec. 284.10(b).
* * * * *
4. Section 284.10 is added to read as follows:
Sec. 284.10 Standards for Pipeline Business Operations and
Communications.
(a) Electronic Bulletin Boards. An interstate pipeline that is
required by this chapter or by its tariff to display information on an
Electronic Bulletin Board must provide for the following features on
its board:
(1) Downloading by users,
(2) Daily back-up of information displayed on the board, which must
be available for user review for at least three years,
(3) Purging of information on completed transactions from current
files,
(4) Display of most recent entries ahead of information posted
earlier, and
(5) On-line help, a search function that permits users to locate
all information concerning a specific transaction, and a menu that
permits users to separately access the notices of available capacity,
the marketing affiliate discount information, the marketing affiliate
capacity allocation log, and the standards of conduct information.
(b) Incorporation by Reference of Business Practice and Electronic
Communication Standards. (1)(i) An interstate pipeline that transports
gas under subpart B or G of this part must comply with the following
business practice and electronic communication standards promulgated by
the Gas Industry Standards Board, which are incorporated herein by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51:
(A) Nominations Definitions 1.2.1 through 1.2.4 (Version 1),
Standards 1.3.1 through 1.3.23 (Version 1), and Data Sets 1.4.1 through
1.4.5 (Version 1);
(B) Flowing Gas Standards 2.3.1 through 2.3.28 (Version 1) and Data
Sets 2.4.1 through 2.4.4 (Version 1);
(C) Invoicing Definition 3.2.1 (Version 1), Standards 3.3.1 through
3.3.21 (Version 1), and Data Sets 3.4.1 through 3.4.3 (Version 1);
(D) Electronic Delivery Mechanisms Standards 4.3.1 through 4.3.4
(Version 1), except that pipelines must comply with Standards 4.3.1 and
4.3.2 by January 1, 1997;
(E) Capacity Release Definition 5.2.1 (Version 1), Standards 5.3.1
through 5.3.29 (Version 1), and Data Sets 5.4.1 through 5.4.20 (Version
1);
(F) Electronic Data Interchange Implementation Guide, Capacity
Release (Version 1.0).
(ii) Copies of these standards may be obtained from the Gas
Industry Standards Board, 1100 Louisiana, Suite 4925, Houston, TX
77002. Copies may be inspected and copied at the Federal Energy
Regulatory Commission, Public Reference and Files Maintenance Branch,
888 First Street, N.E., Washington, DC 20426.
(2) Interstate pipelines must comply with these standards and
protocols by January 1, 1997.
Note--The following appendix will not appear in the Code of
Federal Regulations
Appendix.--RM96-1-000--Comments Filed
------------------------------------------------------------------------
Commenters Abbreviations
------------------------------------------------------------------------
American Forest & Paper AF&PA.
Association.
Associated Gas Distributors... AGD.
Brooklyn Union Gas Company.... Brooklyn Union.
Central Illinois Light Company CILCO.
CNG Transmission Corporation.. CNG Transmission.
CNG Energy Services CNG ESC.
Corporation.
Coastal Gas Marketing Company. Coastal.
Colorado Interstate Gas CIG/ANR.
Company and ANR Pipeline
Company.
Consolidated Natural Gas CNG.
System.
East Ohio Gas Co., Hope Gas, CNG LDCs.
Inc., The Peoples Natural Gas
Co., Virginia Natural Gas,
Inc., & West Ohio Natural Gas
Co..
Energy Managers Association... EMA.
EnerSoft Corp. and NYMEX EnerSoft/NYMEX
Technology Corp..
Equitrans, L.P................ Equitrans.
GasEDI........................ GasEDI.
Gas Industry Standards Board.. GISB.
GISB Services Segment GISB Services Segment.
Executive Committee Members.
Independent Petroleum IPAA.
Association of America.
Interstate Natural Gas INGAA.
Association of America.
Iroquois Gas Transmission Iroquois.
System, L.P..
Koch Gateway Pipeline Company. Koch Gateway.
Midland Cogeneration Venture MCV.
Limited Partnership.
Minnegasco.................... Minnegasco.
Natural Gas Clearinghouse, NGC/Conoco/Vastar.
Conoco, Inc. and Vastar Gas
Marketing, Inc..
Natural Gas Council........... Natural Gas Council.
Natural Gas Pipeline Company Natural.
of America.
Natural Gas Supply Association NGSA.
NorAm Energy Services, Inc.... NES.
Northern Distributor Group.... NDG.
[[Page 19220]]
Northern Indiana Public Northern Indiana Distributors.
Service Company, Northern
Indiana Fuel and Light
Company, and Kokomo Gas and
Fuel Company.
Northwest Industrial Gas Users NWIGU.
Pacific Gas and Electric PG&E.
Company.
Pacific Gas Transmission PGT.
Company.
PanEnergy Companies........... PanEnergy.
SABRE Decision Technologies... SDT.
Southern California Edison Edison.
Company.
The Peoples Gas Light and Coke Peoples.
Company, North Shore Gas
Company, and Northern
Illinois Gas Company.
TransCapacity Limited TransCapacity.
Partnership.
United Distribution Companies. UDC.
Williams Interstate Natural WINGS.
Gas System.
Williston Basin Interstate Williston.
Pipeline Company.
------------------------------------------------------------------------
[FR Doc. 96-10587 Filed 4-30-96; 8:45 am]
BILLING CODE 6717-01-P
Complete official Federal Register PDF
FR Doc. 96-10165 37.0-38.6 GHz and 38.6-40.0 GHz Bands and Implementation of Section 309(j) of the Communications ActCompetitive Bidding
[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Page 19236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10165]
=======================================================================
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Parts 1, 2, 21 and 94
[ET Docket No. 95-183; PP Docket No. 93-253; DA 96-455]
37.0-38.6 GHz and 38.6-40.0 GHz Bands and Implementation of
Section 309(j) of the Communications Act--Competitive Bidding
AGENCY: Federal Communications Commission.
ACTION: Proposed rule; denial of request for extension of time.
-----------------------------------------------------------------------
SUMMARY: The Commission denies an extension of time for filing reply
comments in this proceeding on licensing and technical rules for fixed
point-to-point microwave operations in the 37.0-38.6 GHz and 38.6-40.0
GHz bands. This action is taken because the filing dates were
previously extended and it is the Commission's policy that extensions
of time not be routinely granted. The intended effect of this action is
to expedite the resolution of the issues raised in this proceeding.
DATES: Reply comments were due on April 1, 1996.
ADDRESSES: Federal Communications Commission, 1919 M Street N.W.,
Washington, D.C. 20554.
FOR FURTHER INFORMATION CONTACT: Freda Lippert Thyden, Wireless
Telecommunications Bureau, (202) 418-0627.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Order,
DA 96-455, adopted March 28, 1996 and released March 28, 1996. The
complete text of this document is available for inspection and copying
during normal business hours in the FCC Reference Center (Room 239),
1919 M Street, N.W., Washington, D.C. 20554, and may be purchased from
the Commission's copy contractor, International Transcription Service,
(202) 857-3800, 2100 M Street, N.W., Washington, D.C. 20037.
By this action, we deny a third extension of time in which to file
reply comments in this proceeding. (61 FR 2465, January 26, 1996).
Bachow and Associates, Inc. (``Bachow''), requested that the time for
filing reply comments in this proceeding be extended from April 1, 1996
to April 22, 1996.
By way of background, on January 16, 1996, the Commission's Office
of Engineering Technology, on its own motion, extended the initial
comment and reply comment period in the above-captioned proceeding from
January 16, 1996, and January 31, 1996, respectively, to February 12,
1996, and February 27, 1996, respectively. On February 9, 1996, the
Private Wireless Division further extended the deadline for filing
comments and replies to March 4, 1996, and April 1, 1996, respectively,
at the request of Winstar Wireless Fiber Corporation, GHz Equipment
Company, Inc., and the Fixed Point-to-Point Communications Section,
Network Equipment Division of the Telecommunications Industry
Association (61 FR 6809, February 22, 1996).
Bachow contends that the volume of comments, the number and
complexity of the issues involved and the initial delay in availability
of filed comments necessitate an extension of three weeks for the
filing of replies. We disagree. The facts of this case do not warrant
what, in essence, would be a third extension of the filing period. It
is the policy of the Commission that extensions of time not be
routinely granted. Upon granting the last extension, the public was
fully apprised of our increasing concern over the delay in this
proceeding. In requesting additional time, Bachow has failed to cite
any convincing reason for again postponing the deadline for filing
reply comments.
Ordering Clauses
Accordingly, it is hereby ordered that the Motion for Extension of
Time to File Reply Comments filed by Bachow and Associates, Inc., on
March 25, 1996 is denied.
This action is taken pursuant to the authority provided in Section
1.46 of the Commission's Rules.
Federal Communications Commission.
Robert H. McNamara,
Chief, Private Wireless Division, Wireless Telecommunications Bureau.
[FR Doc. 96-10165 Filed 4-30-96; 8:45 am]
BILLING CODE 6712-01-P
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